Fluocinonide Cream in Treating Symptoms of Vaginal Dryness and Painful Sexual Intercourse In Patients With Breast Cancer Undergoing Hormone Therapy
This phase II trial studies how well giving fluocinonide cream works in treating symptoms of vaginal dryness and painful sexual intercourse in patients with breast cancer undergoing hormone therapy. Fluocinonide cream may prevent or lessen vaginal dryness and painful sexual intercourse in patients undergoing hormone therapy
Other: questionnaire administration
Drug: fluocinonide cream
Procedure: management of therapy complications
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Phase II Study of the Effect of the Topical Corticosteroid Fluocinonide in Patients on Endocrine Therapy for Either Breast Cancer or an Increased Risk for Breast Cancer With Symptoms of Vaginal Dryness and Dyspareunia|
- Decrease in symptoms of vaginal dryness and dyspareunia after 4 weeks of treatment [ Time Frame: Baseline, weekly until 28 days ] [ Designated as safety issue: No ]Decrease in symptoms 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 five (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.
- Vaginal itching [ Time Frame: Baseline, at the end of 4 weeks ] [ Designated as safety issue: No ]
- Total vaginal index score (dryness, itching, and dyspareunia) [ Time Frame: Baseline, at the end of 4 weeks ] [ Designated as safety issue: No ]
- Number of patients experiencing toxicities [ Time Frame: Baseline, weekly for 28 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2011|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Experimental: Supportive care (fluocinonide cream)
Patients apply topical fluocinonide cream BID in weeks 1-2 and QD in weeks 3-4.
Other: questionnaire administration
Ancillary studiesDrug: fluocinonide cream
Other Names:Procedure: management of therapy complications
Receive fluocinonide cream
Other Name: complications of therapy, management of
I. To estimate the decrease in symptoms of vaginal dryness and dyspareunia with the use of fluocinonide 0.05% cream in breast cancer patients on adjuvant endocrine therapy. Estimates of decrease will be obtained utilizing patient survey instruments.
I. To estimate the decrease in symptoms of vaginal itching and the total vaginal index score with the use of fluocinonide 0.05% cream in breast cancer patients on adjuvant endocrine therapy. Estimates of decrease will be obtained utilizing patient survey instruments.
II. To explore toxicities reported by patients using fluocinonide 0.05% cream via vaginal application.
III. To explore the correlations between patient characteristics and response rates with the use of fluocinonide 0.05% cream.
Patients apply topical fluocinonide cream twice daily (BID) in weeks 1-2 and once daily (QD) in weeks 3-4.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01422408
|United States, Oregon|
|OHSU Knight Cancer Institute||Recruiting|
|Portland, Oregon, United States, 97239|
|Contact: Stephen Y. Chui firstname.lastname@example.org|
|Contact: Kristine Lethert, M.D. email@example.com|
|Principal Investigator: Stephen Y. Chui|
|Principal Investigator:||Stephen Chui||OHSU Knight Cancer Institute|