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
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
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Decrease in symptoms of vaginal dryness and dyspareunia after 4 weeks of treatment
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.
Baseline, weekly until 28 days
OHSU Knight Cancer Institute
United States: Institutional Review Board
|OHSU Knight Cancer Institute||Portland, Oregon 97239|