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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Supportive Care (Fluocinonide Cream)

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.


Participant Flow:   Overall Study
    Supportive Care (Fluocinonide Cream)
STARTED   34 
COMPLETED   30 
NOT COMPLETED   4 
Adverse Event                1 
Withdrawal by Subject                3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Supportive Care

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.


Baseline Measures
   Supportive Care 
Overall Participants Analyzed 
[Units: Participants]
 34 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      29  85.3% 
>=65 years      5  14.7% 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.44  (9.39) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      34 100.0% 
Male      0   0.0% 
Menopause status [1] 
[Units: Participants]
Count of Participants
 
Pre-menopausal      1   2.9% 
Post-menopausal      33  97.1% 
[1]

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] 
[Units: Participants]
Count of Participants
 
Anastrazole      7  20.6% 
Exemestane      3   8.8% 
Letrozole      13  38.2% 
Tamoxifen      11  32.4% 
[1]

type of endocrine therapy currently taken by the subject

tamoxifen vs. anastrazole vs. letrozole vs. exemestane

Prior cytotoxic chemotherapy received [1] 
[Units: Participants]
Count of Participants
 
Prior cytotoxic chemotherapy      14  41.2% 
No prior cytotoxic chemotherapy      20  58.8% 
[1] 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] 
[Units: Participants]
Count of Participants
 
Adjuvant      33  97.1% 
Prophylaxis      1   2.9% 
[1] 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] 
[Units: Participants]
Count of Participants
 
Severe      15  44.1% 
Not severe      19  55.9% 
[1] Severe symptoms indicated by a score of 3 or 4. Measured at study baseline
Severe baseline symptoms, Dyspareunia [1] 
[Units: Participants]
Count of Participants
 
Severe      15  44.1% 
Not severe      10  29.4% 
Missing/not reported      9  26.5% 
[1] Severe symptoms indicated by a score of 3 or 4. Measured at study baseline
Severe baseline symptoms, Itching [1] 
[Units: Participants]
Count of Participants
 
Severe      1   2.9% 
Not severe      33  97.1% 
[1] Severe symptoms indicated by a score of 3 or 4. Measured at study baseline


  Outcome Measures

1.  Primary:   Change in Symptom Scores of Vaginal Dryness   [ Time Frame: Baseline and 4 weeks ]

2.  Primary:   Change in Symptom Scores of Dyspareunia   [ Time Frame: Baseline and 4 weeks ]

3.  Secondary:   Change in Symptom Scores of Vaginal Itching   [ Time Frame: Baseline and 4 weeks ]

4.  Secondary:   Change in Total Vaginal Index Score.   [ Time Frame: Baseline and 4 weeks ]

5.  Secondary:   Number of Patients Experiencing Toxicities   [ Time Frame: Over 4 weeks ]

6.  Secondary:   Change in Vaginal Dryness Symptom Scores by Age Characteristics   [ Time Frame: Baseline and 4 weeks ]

7.  Secondary:   Change in Dyspareunia Symptom Scores by Age Characteristics   [ Time Frame: Baseline and 4 weeks ]

8.  Secondary:   Change in Vaginal Itching Symptom Scores by Age Characteristics   [ Time Frame: Baseline and 4 weeks ]

9.  Secondary:   Change in Vaginal Dryness Symptom Scores by Menopause Status Characteristics   [ Time Frame: Baseline and 4 weeks ]

10.  Secondary:   Change in Dyspareunia Symptom Scores by Menopause Status Characteristics   [ Time Frame: Baseline and 4 weeks ]

11.  Secondary:   Change in Vaginal Itching Symptom Scores by Menopause Status Characteristics   [ Time Frame: Baseline and 4 weeks ]

12.  Secondary:   Change in Vaginal Dryness Symptom Scores by Current Endocrine Therapy Characteristics   [ Time Frame: Baseline and 4 weeks ]

13.  Secondary:   Change in Dyspareunia Symptom Scores by Current Endocrine Therapy Characteristics   [ Time Frame: Baseline and 4 weeks ]

14.  Secondary:   Change in Vaginal Itching Symptom Scores by Current Endocrine Therapy Characteristics   [ Time Frame: Baseline and 4 weeks ]

15.  Secondary:   Change in Vaginal Dryness Symptom Scores by Prior Cytotoxic Therapy Characteristics   [ Time Frame: Baseline and 4 weeks ]

16.  Secondary:   Change in Dyspareunia Symptom Scores by Prior Cytotoxic Therapy Characteristics   [ Time Frame: Baseline and 4 weeks ]

17.  Secondary:   Change in Vaginal Itching Symptom Scores by Prior Cytotoxic Therapy Characteristics   [ Time Frame: Baseline and 4 weeks ]

18.  Secondary:   Change in Vaginal Dryness Symptom Scores by Indication for Endocrine Therapy Characteristics   [ Time Frame: Baseline and 4 weeks ]

19.  Secondary:   Change in Dyspareunia Symptom Scores by Indication for Endocrine Therapy Characteristics   [ Time Frame: Baseline and 4 weeks ]

20.  Secondary:   Change in Vaginal Itching Symptom Scores by Indication for Endocrine Therapy Characteristics   [ Time Frame: Baseline and 4 weeks ]

21.  Secondary:   Change in Vaginal Dryness Symptom Scores by Patient Reported Compliance Characteristics   [ Time Frame: Baseline and 4 weeks ]

22.  Secondary:   Change in Dyspareunia Symptom Scores by Patient Reported Compliance Characteristics   [ Time Frame: Baseline and 4 weeks ]

23.  Secondary:   Change in Vaginal Itching Symptom Scores by Patient Reported Compliance Characteristics   [ Time Frame: Baseline and 4 weeks ]

24.  Secondary:   Change in Vaginal Dryness Symptom Scores by Tube Weight Based Compliance Characteristics   [ Time Frame: Baseline and 4 weeks ]

25.  Secondary:   Change in Dyspareunia Symptom Scores by Tube Weight Based Compliance Characteristics   [ Time Frame: Baseline and 4 weeks ]

26.  Secondary:   Change in Vaginal Itching Symptom Scores by Tube Weight Based Compliance Characteristics   [ Time Frame: Baseline and 4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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


  More Information

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
e-mail: latour@ohsu.edu



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