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Fluocinonide Cream in Treating Symptoms of Vaginal Dryness and Painful Sexual Intercourse In Patients With Breast Cancer Undergoing Hormone Therapy

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ClinicalTrials.gov Identifier: NCT01422408
Recruitment Status : Completed
First Posted : August 24, 2011
Results First Posted : August 9, 2017
Last Update Posted : August 9, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Kathleen Kemmer, OHSU Knight Cancer Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Breast Carcinoma
Interventions Drug: Fluocinonide Cream
Procedure: Management of Therapy Complications
Other: Questionnaire Administration
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Supportive Care (Fluocinonide Cream)
Hide Arm/Group Description

This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.

All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.

Period Title: Overall Study
Started 34
Completed 30
Not Completed 4
Reason Not Completed
Adverse Event             1
Withdrawal by Subject             3
Arm/Group Title Supportive Care
Hide Arm/Group Description

This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.

All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.

Overall Number of Baseline Participants 34
Hide Baseline Analysis Population Description
An intent-to-treat analysis set will include those who are enrolled in the trial regardless of the number of treatments received. All primary analyses will be conducted using the intent-to-treat analysis set. A safety analysis set will include those who receive at least one treatment.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
<=18 years
0
   0.0%
Between 18 and 65 years
29
  85.3%
>=65 years
5
  14.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants
55.44  (9.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Female
34
 100.0%
Male
0
   0.0%
Menopause status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Pre-menopausal
1
   2.9%
Post-menopausal
33
  97.1%
[1]
Measure Description:

Pre-menopausal versus post-menopausal (defined as either no menses ≥ 12 months, medical ovarian suppression with leuprolide or goserelin, bilateral ovarian ablation with radiation, or bilateral oophorectomy)

The subject’s menopausal status will be classified according to the menopausal status at the time of enrollment on study.

Current endocrine therapy   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Anastrazole
7
  20.6%
Exemestane
3
   8.8%
Letrozole
13
  38.2%
Tamoxifen
11
  32.4%
[1]
Measure Description:

type of endocrine therapy currently taken by the subject

tamoxifen vs. anastrazole vs. letrozole vs. exemestane

Prior cytotoxic chemotherapy received   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Prior cytotoxic chemotherapy
14
  41.2%
No prior cytotoxic chemotherapy
20
  58.8%
[1]
Measure Description: Whether the subject has received prior cytotoxic chemotherapy for breast cancer: prior cytotoxic chemotherapy versus no prior cytotoxic chemotherapy for breast cancer
Indications for endocrine therapy   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Adjuvant
33
  97.1%
Prophylaxis
1
   2.9%
[1]
Measure Description: use of endocrine therapy for preventative treatment with an increased risk for breast cancer vs. adjuvant treatment for a history of invasive breast cancer
Severe baseline symptoms, Dryness   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Severe
15
  44.1%
Not severe
19
  55.9%
[1]
Measure Description: Severe symptoms indicated by a score of 3 or 4. Measured at study baseline
Severe baseline symptoms, Dyspareunia   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Severe
15
  44.1%
Not severe
10
  29.4%
Missing/not reported
9
  26.5%
[1]
Measure Description: Severe symptoms indicated by a score of 3 or 4. Measured at study baseline
Severe baseline symptoms, Itching   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Severe
1
   2.9%
Not severe
33
  97.1%
[1]
Measure Description: Severe symptoms indicated by a score of 3 or 4. Measured at study baseline
1.Primary Outcome
Title Change in Symptom Scores of Vaginal Dryness
Hide Description

Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints.

Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Time Frame Baseline and 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Supportive Care (Fluocinonide Cream)
Hide Arm/Group Description:

This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.

All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.

Overall Number of Participants Analyzed 34
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
-2
(-3 to -1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Supportive Care (Fluocinonide Cream)
Comments The primary endpoints (i.e., change in symptoms of vaginal dryness from the baseline to 4 weeks, and change in symptoms of dyspareunia from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints.
Type of Statistical Test Other
Comments Two-sided test that the change is different from zero. Not tested against alternative treatment; single arm study.
Statistical Test of Hypothesis P-Value <0.001
Comments 2.5% significance level to account for two co-primary endpoints.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Supportive Care (Fluocinonide Cream)
Comments GEE (general estimating equation) methods were planned as a secondary analysis of the primary endpoints. Missing data for some of the weeks prevented these models from converging and we could not obtain valid results with these methods. Since this is a secondary analysis, we decided to compare symptom severity at baseline vs. week 4 (end of study). Symptoms are considered "severe" for scores 3 or 4 and "not severe" for scores 0, 1, 2
Type of Statistical Test Other
Comments Exact McNemar's test was used to test if the proportion of severe symptoms at baseline are equal to the proportion of severe symptoms at the end of the study.
Statistical Test of Hypothesis P-Value 0.001
Comments Since there are two-co-primary endpoints, the significance level is 2.5%
Method McNemar
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0
Confidence Interval (2-Sided) 95%
0 to 0.36
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change in Symptom Scores of Dyspareunia
Hide Description

Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints.

Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Time Frame Baseline and 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Supportive Care (Fluocinonide Cream)
Hide Arm/Group Description:

This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.

All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.

Overall Number of Participants Analyzed 34
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
-2
(-3 to -1.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Supportive Care (Fluocinonide Cream)
Comments The primary endpoints (i.e., change in symptoms of vaginal dryness from the baseline to 4 weeks, and change in symptoms of dyspareunia from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints.
Type of Statistical Test Other
Comments Two-sided test that the change is different from zero. Not tested against alternative treatment; single arm study.
Statistical Test of Hypothesis P-Value 0.002
Comments 2.5% significance level to account for two co-primary endpoints.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Supportive Care (Fluocinonide Cream)
Comments GEE (general estimating equations) methods were planned as a secondary analysis of the primary endpoints. Missing data for some of the weeks prevented these models from converging and we could not obtain valid results with these methods. Since this is a secondary analysis, we decided to compare symptom severity at baseline vs. week 4 (end of study). Symptoms are considered "severe" for scores 3 or 4 and "not severe" for scores 0, 1, 2
Type of Statistical Test Other
Comments Exact McNemar's test was used to test if the proportion of severe symptoms at baseline are equal to the proportion of severe symptoms at the end of the study.
Statistical Test of Hypothesis P-Value 0.062
Comments Since there are two-co-primary endpoints, the significance level is 2.5%
Method McNemar
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0
Confidence Interval (2-Sided) 95%
0 to 1.09
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change in Symptom Scores of Vaginal Itching
Hide Description

Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints.

Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Time Frame Baseline and 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Supportive Care (Fluocinonide Cream)
Hide Arm/Group Description:

This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.

All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.

Overall Number of Participants Analyzed 34
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
-1
(-2 to 0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Supportive Care (Fluocinonide Cream)
Comments The secondary endpoints (i.e., change in symptoms of vaginal itching from the baseline to 4 weeks, and change in vaginal index score from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints.
Type of Statistical Test Other
Comments Two-sided test that the change is different from zero. Not tested against alternative treatment; single arm study.
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Change in Total Vaginal Index Score.
Hide Description

Change in total vaginal index score. The total vaginal index score is a numerical value ranging from zero to twelve, comprised of the three components of vaginal dryness, vaginal itching, and dyspareunia graded on an ordinal scale of zero to four added together.

Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -12 to +12; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints.

Time Frame Baseline and 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Supportive Care (Fluocinonide Cream)
Hide Arm/Group Description:

This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.

All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.

Overall Number of Participants Analyzed 34
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
-5
(-6 to -3.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Supportive Care (Fluocinonide Cream)
Comments The secondary endpoints (i.e., change in symptoms of vaginal itching from the baseline to 4 weeks, and change in vaginal index score from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints.
Type of Statistical Test Other
Comments 2.5% significance level to account for two co-primary endpoints.
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Number of Patients Experiencing Toxicities
Hide Description Toxicity data will be reported as descriptive data as the percentage of patients experiencing reported side effects. Toxicity and safety analyses will be conducted using the safety analysis set.
Time Frame Over 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Toxicity and safety analyses will be conducted using the safety analysis set.
Arm/Group Title Supportive Care (Fluocinonide Cream)
Hide Arm/Group Description:

This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.

All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.

Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
1
   2.9%
6.Secondary Outcome
Title Change in Vaginal Dryness Symptom Scores by Age Characteristics
Hide Description

Association of response in symptoms with characteristics of the subject population (Dryness and Age)

Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.

Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Time Frame Baseline and 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
Arm/Group Title Supportive Care (Fluocinonide Cream)
Hide Arm/Group Description:

This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.

All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.

Overall Number of Participants Analyzed 34
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
Age 18-45 Number Analyzed 6 participants
-1.5
(-2.5 to -1.0)
Age 46-55 Number Analyzed 10 participants
-2.0
(-3.0 to -2.0)
Age 56-65 Number Analyzed 13 participants
-2.0
(-2.0 to -1.5)
Age > 65 Number Analyzed 5 participants
-2.0
(-3.0 to -0.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Supportive Care (Fluocinonide Cream)
Comments In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1029
Comments No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
Method ANOVA
Comments Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.
7.Secondary Outcome
Title Change in Dyspareunia Symptom Scores by Age Characteristics
Hide Description

Association of response in symptoms with characteristics of the subject population (Dyspareunia and Age)

Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.

Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Time Frame Baseline and 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
Arm/Group Title Supportive Care (Fluocinonide Cream)
Hide Arm/Group Description:

This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.

All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.

Overall Number of Participants Analyzed 34
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
Age 18-45 Number Analyzed 6 participants
-1
(-1 to -1)
Age 46-55 Number Analyzed 10 participants
-2
(-2 to -2)
Age 56-65 Number Analyzed 13 participants
-2.5
(-3 to -1.75)
Age > 65 Number Analyzed 5 participants
-3
(-3 to -3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Supportive Care (Fluocinonide Cream)
Comments In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2678
Comments No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
Method ANOVA
Comments Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.
8.Secondary Outcome
Title Change in Vaginal Itching Symptom Scores by Age Characteristics
Hide Description

Association of response in symptoms with characteristics of the subject population (Itching and Age)

Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.

Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Time Frame Baseline and 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
Arm/Group Title Supportive Care (Fluocinonide Cream)
Hide Arm/Group Description:

This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.

All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.

Overall Number of Participants Analyzed 34
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
Age 18-45 Number Analyzed 6 participants
-0.5
(-1.25 to 0.25)
Age 46-55 Number Analyzed 10 participants
-1
(-2 to 0)
Age 56-65 Number Analyzed 13 participants
-1
(-1.75 to 0)
Age > 65 Number Analyzed 5 participants
-0.5
(-1.25 to 0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Supportive Care (Fluocinonide Cream)
Comments In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2472
Comments No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
Method ANOVA
Comments Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.
9.Secondary Outcome
Title Change in Vaginal Dryness Symptom Scores by Menopause Status Characteristics
Hide Description

Association of response in symptoms with characteristics of the subject population (Dryness and Menopause status)

Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.

Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Time Frame Baseline and 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
Arm/Group Title Supportive Care (Fluocinonide Cream)
Hide Arm/Group Description:

This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.

All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.

Overall Number of Participants Analyzed 34
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
Pre-Menopause Number Analyzed 1 participants
-2
(-2 to -2)
Post-menopause Number Analyzed 33 participants
-2
(-3 to -1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Supportive Care (Fluocinonide Cream)
Comments In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.507
Comments No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
Method ANOVA
Comments Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.
10.Secondary Outcome
Title Change in Dyspareunia Symptom Scores by Menopause Status Characteristics
Hide Description

Association of response in symptoms with characteristics of the subject population (Dyspareunia and Menopause status)

Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.

Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Time Frame Baseline and 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
Arm/Group Title Supportive Care (Fluocinonide Cream)
Hide Arm/Group Description:

This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.

All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.

Overall Number of Participants Analyzed 34
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
Pre-Menopause Number Analyzed 1 participants
NA [1] 
(NA to NA)
Post-menopause Number Analyzed 33 participants
-2
(-3 to -1.75)
[1]
Missing data for the one subject in this group.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Supportive Care (Fluocinonide Cream)
Comments In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3676
Comments No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
Method ANOVA
Comments Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.
11.Secondary Outcome
Title Change in Vaginal Itching Symptom Scores by Menopause Status Characteristics
Hide Description

Association of response in symptoms with characteristics of the subject population (Itching and Menopause status)

Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.

Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Time Frame Baseline and 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
Arm/Group Title Supportive Care (Fluocinonide Cream)
Hide Arm/Group Description:

This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.

All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.

Overall Number of Participants Analyzed 34
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
Pre-Menopause Number Analyzed 1 participants
-1
(-1 to -1)
Post-menopause Number Analyzed 33 participants
-1
(-2 to 0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Supportive Care (Fluocinonide Cream)
Comments In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6023
Comments No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
Method ANOVA
Comments Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.
12.Secondary Outcome
Title Change in Vaginal Dryness Symptom Scores by Current Endocrine Therapy Characteristics
Hide Description

Association of response in symptoms with characteristics of the subject population (Dryness and current endocrine therapy)

Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.

Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Time Frame Baseline and 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
Arm/Group Title Supportive Care (Fluocinonide Cream)
Hide Arm/Group Description:

This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.

All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.

Overall Number of Participants Analyzed 34
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
Anastrazole Number Analyzed 7 participants
-2
(-2.75 to -2.0)
Exemestane Number Analyzed 3 participants
-2
(-2.5 to -1.5)
Letrozole Number Analyzed 13 participants
-2
(-3 to -1)
Tamoxifen Number Analyzed 11 participants
-2
(-2 to -1.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Supportive Care (Fluocinonide Cream)
Comments In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6587
Comments No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
Method ANOVA
Comments Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.
13.Secondary Outcome
Title Change in Dyspareunia Symptom Scores by Current Endocrine Therapy Characteristics
Hide Description

Association of response in symptoms with characteristics of the subject population (Dyspareunia and current endocrine therapy)

Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.

Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Time Frame Baseline and 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
Arm/Group Title Supportive Care (Fluocinonide Cream)
Hide Arm/Group Description:

This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.

All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.

Overall Number of Participants Analyzed 34
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
Anastrazole Number Analyzed 7 participants
-2
(-2.5 to -1.5)
Exemestane Number Analyzed 3 participants
-2
(-2 to -2)
Letrozole Number Analyzed 13 participants
-2.5
(-3 to -2)
Tamoxifen Number Analyzed 11 participants
-1.5
(-1.75 to -1.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Supportive Care (Fluocinonide Cream)
Comments In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8772
Comments No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
Method ANOVA
Comments Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.
14.Secondary Outcome
Title Change in Vaginal Itching Symptom Scores by Current Endocrine Therapy Characteristics
Hide Description

Association of response in symptoms with characteristics of the subject population (Itching and current endocrine therapy)

Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.

Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Time Frame Baseline and 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
Arm/Group Title Supportive Care (Fluocinonide Cream)
Hide Arm/Group Description:

This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.

All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.

Overall Number of Participants Analyzed 34
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
Anastrazole Number Analyzed 7 participants
-0.5
(-1 to 0)
Exemestane Number Analyzed 3 participants
-1
(-1.5 to -0.5)
Letrozole Number Analyzed 13 participants
-0.5
(-2 to 0)
Tamoxifen Number Analyzed 11 participants
-1
(-1.75 to -1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Supportive Care (Fluocinonide Cream)
Comments In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7395
Comments No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
Method ANOVA
Comments Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.
15.Secondary Outcome
Title Change in Vaginal Dryness Symptom Scores by Prior Cytotoxic Therapy Characteristics
Hide Description

Association of response in symptoms with characteristics of the subject population (Dryness and prior cytotoxic therapy)

Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.

Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Time Frame Baseline and 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
Arm/Group Title Supportive Care (Fluocinonide Cream)
Hide Arm/Group Description:

This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.

All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.

Overall Number of Participants Analyzed 34
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
Yes Number Analyzed 14 participants
-2
(-2 to -1)
No Number Analyzed 20 participants
-2
(-3 to -1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Supportive Care (Fluocinonide Cream)
Comments In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9618
Comments No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
Method ANOVA
Comments Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.
16.Secondary Outcome
Title Change in Dyspareunia Symptom Scores by Prior Cytotoxic Therapy Characteristics
Hide Description

Association of response in symptoms with characteristics of the subject population (Dyspareunia and prior cytotoxic therapy)

Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.

Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Time Frame Baseline and 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
Arm/Group Title Supportive Care (Fluocinonide Cream)
Hide Arm/Group Description:

This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.

All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.

Overall Number of Participants Analyzed 34
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
Yes Number Analyzed 14 participants
-2
(-2.25 to -1)
No Number Analyzed 20 participants
-2.5
(-3 to -2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Supportive Care (Fluocinonide Cream)
Comments In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5113
Comments No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
Method ANOVA
Comments Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.
17.Secondary Outcome
Title Change in Vaginal Itching Symptom Scores by Prior Cytotoxic Therapy Characteristics
Hide Description

Association of response in symptoms with characteristics of the subject population (Itching and prior cytotoxic therapy)

Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.

Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Time Frame Baseline and 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
Arm/Group Title Supportive Care (Fluocinonide Cream)
Hide Arm/Group Description:

This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.

All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.

Overall Number of Participants Analyzed 34
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
Yes Number Analyzed 14 participants
-1
(-1 to 0)
No Number Analyzed 20 participants
-1
(-2 to 0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Supportive Care (Fluocinonide Cream)
Comments In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8833
Comments No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
Method ANOVA
Comments Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.
18.Secondary Outcome
Title Change in Vaginal Dryness Symptom Scores by Indication for Endocrine Therapy Characteristics
Hide Description

Association of response in symptoms with characteristics of the subject population (Dryness and Indications)

Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.

Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Time Frame Baseline and 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
Arm/Group Title Supportive Care (Fluocinonide Cream)
Hide Arm/Group Description:

This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.

All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.

Overall Number of Participants Analyzed 34
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
Adjuvant Number Analyzed 33 participants
-2
(-2.5 to -1)
Prophylaxis Number Analyzed 1 participants
-3
(-3 to -3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Supportive Care (Fluocinonide Cream)
Comments In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7983
Comments No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
Method ANOVA
Comments Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.
19.Secondary Outcome
Title Change in Dyspareunia Symptom Scores by Indication for Endocrine Therapy Characteristics
Hide Description

Association of response in symptoms with characteristics of the subject population (Dyspareunia and Indications)

Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.

Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Time Frame Baseline and 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
Arm/Group Title Supportive Care (Fluocinonide Cream)
Hide Arm/Group Description:

This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.

All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.

Overall Number of Participants Analyzed 34
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
Adjuvant Number Analyzed 33 participants
-2
(-3 to -1.75)
Prophylaxis Number Analyzed 1 participants
NA [1] 
(NA to NA)
[1]
Data for single participant is missing
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Supportive Care (Fluocinonide Cream)
Comments In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4937
Comments No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
Method ANOVA
Comments Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.
20.Secondary Outcome
Title Change in Vaginal Itching Symptom Scores by Indication for Endocrine Therapy Characteristics
Hide Description

Association of response in symptoms with characteristics of the subject population (Itching and Indications)

Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.

Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Time Frame Baseline and 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
Arm/Group Title Supportive Care (Fluocinonide Cream)
Hide Arm/Group Description:

This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.

All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.

Overall Number of Participants Analyzed 34
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
Adjuvant Number Analyzed 33 participants
-1
(-1.75 to 0)
Prophylaxis Number Analyzed 1 participants
-2
(-2 to -2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Supportive Care (Fluocinonide Cream)
Comments In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9106
Comments No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
Method ANOVA
Comments Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.
21.Secondary Outcome
Title Change in Vaginal Dryness Symptom Scores by Patient Reported Compliance Characteristics
Hide Description

Association of response in symptoms with patient reported compliance (Dryness)

Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance.

Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Groups are made by % of compliance reported by patients

Time Frame Baseline and 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
Arm/Group Title Supportive Care (Fluocinonide Cream)
Hide Arm/Group Description:

This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.

All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.

Overall Number of Participants Analyzed 34
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
50 - 74% Number Analyzed 1 participants
-2
(-2 to -2)
>= 75% Number Analyzed 29 participants
-2
(-3 to -1)
Missing / not reported Number Analyzed 4 participants
NA [1] 
(NA to NA)
[1]
Data is missing for these patients
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Supportive Care (Fluocinonide Cream)
Comments In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.507
Comments No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
Method ANOVA
Comments Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.
22.Secondary Outcome
Title Change in Dyspareunia Symptom Scores by Patient Reported Compliance Characteristics
Hide Description

Association of response in symptoms with patient reported compliance (Dyspareunia)

Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance.

Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Groups are made by % of compliance reported by patients

Time Frame Baseline and 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
Arm/Group Title Supportive Care (Fluocinonide Cream)
Hide Arm/Group Description:

This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.

All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.

Overall Number of Participants Analyzed 34
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
50 - 74% Number Analyzed 1 participants
NA [1] 
(NA to NA)
>= 75% Number Analyzed 29 participants
-2
(-3 to -1.75)
Missing / not reported Number Analyzed 4 participants
NA [1] 
(NA to NA)
[1]
Data is missing; could not calculate
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Supportive Care (Fluocinonide Cream)
Comments In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3676
Comments No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
Method ANOVA
Comments Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.
23.Secondary Outcome
Title Change in Vaginal Itching Symptom Scores by Patient Reported Compliance Characteristics
Hide Description

Association of response in symptoms with patient reported compliance (Itching)

Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance.

Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Groups are made by % of compliance reported by patients

Time Frame Baseline and 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
Arm/Group Title Supportive Care (Fluocinonide Cream)
Hide Arm/Group Description:

This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.

All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.

Overall Number of Participants Analyzed 34
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
50 - 74% Number Analyzed 1 participants
-1
(-1 to -1)
>= 75% Number Analyzed 29 participants
-1
(-2 to 0)
Missing / not reported Number Analyzed 4 participants
NA [1] 
(NA to NA)
[1]
Data is missing; could not calculate.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Supportive Care (Fluocinonide Cream)
Comments In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6023
Comments No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
Method ANOVA
Comments Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.
24.Secondary Outcome
Title Change in Vaginal Dryness Symptom Scores by Tube Weight Based Compliance Characteristics
Hide Description

Association of response in symptoms with tube weight based compliance (Dryness)

Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight.

Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Groups are made by % of tube used by weight.

Time Frame Baseline and 4 weeks
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Hide Analysis Population Description
The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
Arm/Group Title Supportive Care (Fluocinonide Cream)
Hide Arm/Group Description:

This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.

All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.

Overall Number of Participants Analyzed 34
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
< 25% Number Analyzed 5 participants
-1
(-1 to -1)
25 - 49% Number Analyzed 8 participants
-2
(-3 to -1.75)
50 - 74% Number Analyzed 8 participants
-2
(-3 to -1.75)
>= 75% Number Analyzed 7 participants
-2
(-2 to -2)
Missing / not reported Number Analyzed 6 participants
-2.5
(-3.25 to -1.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Supportive Care (Fluocinonide Cream)
Comments In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08531
Comments No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
Method ANOVA
Comments Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.
25.Secondary Outcome
Title Change in Dyspareunia Symptom Scores by Tube Weight Based Compliance Characteristics
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Association of response in symptoms with tube weight based compliance (Dyspareunia)

Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight.

Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Groups are made by % of tube used by weight.

Time Frame Baseline and 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
Arm/Group Title Supportive Care (Fluocinonide Cream)
Hide Arm/Group Description:

This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.

All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.

Overall Number of Participants Analyzed 34
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
< 25% Number Analyzed 5 participants
-1
(-1 to -1)
25 - 49% Number Analyzed 8 participants
-2
(-2.5 to -1.5)
50 - 74% Number Analyzed 8 participants
-2
(-2.25 to -1.75)
>= 75% Number Analyzed 7 participants
-2
(-2.25 to -2)
Missing / not reported Number Analyzed 6 participants
-3
(-3 to -3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Supportive Care (Fluocinonide Cream)
Comments In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2011
Comments No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
Method ANOVA
Comments Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.
26.Secondary Outcome
Title Change in Vaginal Itching Symptom Scores by Tube Weight Based Compliance Characteristics
Hide Description

Association of response in symptoms with tube weight based compliance (Itching)

Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight.

Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Groups are made by % of tube used by weight.

Time Frame Baseline and 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
Arm/Group Title Supportive Care (Fluocinonide Cream)
Hide Arm/Group Description:

This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.

All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.

Overall Number of Participants Analyzed 34
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
< 25% Number Analyzed 5 participants
-1
(-1 to -1)
25 - 49% Number Analyzed 8 participants
-1
(-2 to 0)
50 - 74% Number Analyzed 8 participants
0
(-1 to 0)
>= 75% Number Analyzed 7 participants
-1
(-2 to -0.5)
Missing / not reported Number Analyzed 6 participants
-1
(-1.5 to -0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Supportive Care (Fluocinonide Cream)
Comments In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1187
Comments No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
Method ANOVA
Comments Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.
Time Frame End of study week 1, 2, 3, 4
Adverse Event Reporting Description Toxicities and adverse events will be assessed using the NCI Common Toxicity Criteria (CTC) Version 4.0. Since CTEP has standardized the CTC, the NCI does not require the inclusion of the CTC within the protocol document. A copy can be downloaded from the CTEP home page (http://ctep.info.nih.gov).
 
Arm/Group Title Supportive Care (Fluocinonide Cream)
Hide Arm/Group Description

This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms.

All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.

All-Cause Mortality
Supportive Care (Fluocinonide Cream)
Affected / at Risk (%)
Total   0/34 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Supportive Care (Fluocinonide Cream)
Affected / at Risk (%) # Events
Total   0/34 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Supportive Care (Fluocinonide Cream)
Affected / at Risk (%) # Events
Total   24/34 (70.59%)    
General disorders   
Headache  1  1/34 (2.94%)  1
Skin and subcutaneous tissue disorders   
Bullous dermatitis  1  1/34 (2.94%)  1
Flushing  1  1/34 (2.94%)  1
Pain of skin  1  23/34 (67.65%)  23
Pruritis  1  1/34 (2.94%)  1
Rash acneiform  1  1/34 (2.94%)  1
Vaginal discharge  1  2/34 (5.88%)  2
Vaginal inflammation  1  1/34 (2.94%)  1
1
Term from vocabulary, NCI CTCAE Version 4.
Indicates events were collected by systematic assessment
Original plan was to use GEE modeling for secondary analysis of primary endpoints. Missing data and small counts caused us to perform this analysis using other statistical methods. Data was categorized and tested using McNemar's Test for results
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Emile Latour
Organization: Knight Cancer Institute, Oregon Health & Science University
Phone: 503-418-9601
Responsible Party: Kathleen Kemmer, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT01422408     History of Changes
Other Study ID Numbers: IRB00007265
NCI-2011-01234 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CPC-11028-L ( Other Identifier: OHSU Knight Cancer Institute )
7265 ( Other Identifier: OHSU Knight Cancer Institute )
P30CA69533OD ( Other Grant/Funding Number: National Cancer Institute )
First Submitted: August 22, 2011
First Posted: August 24, 2011
Results First Submitted: March 29, 2017
Results First Posted: August 9, 2017
Last Update Posted: August 9, 2017