NCT01422408

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the decrease in symptoms of vaginal dryness and dyspareunia with the use of fluocinonide 0.05% cream in breast cancer subjects and subjects at increased risk for breast cancer on endocrine therapy. Estimates of decrease will be obtained utilizing patient survey instruments. SECONDARY OBJECTIVES: 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 subjects and subjects at increased risk for breast cancer on endocrine therapy. Estimates of decrease will be obtained utilizing patient survey instruments. II. To explore toxicities reported by subjects using fluocinonide 0.05% cream via vaginal application. III. To explore correlation between subject reported compliance, as well as compliance via measurement of the amount of fluocinonide 0.05% cream used, and response rates with the use of fluocinonide 0.05% cream. IV. To explore the correlations between patient characteristics and response rates with the use of fluocinonide 0.05% cream. OUTLINE: Patients apply topical fluocinonide cream twice daily (BID) in weeks 1-2 and once daily (QD) in weeks 3-4.

Conditions

• Breast Carcinoma

Interventions

Type	Name	Description
DRUG	Fluocinonide Cream	Given topically
PROCEDURE	Management of Therapy Complications	Receive fluocinonide cream
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2011-09-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2011-08-24
• Last updated: 2017-08-09
• Results posted: 2017-08-09

Locations

1 site across 1 country: United States