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

Information source: OHSU Knight Cancer Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Carcinoma

Intervention: Fluocinonide Cream (Drug); Management of Therapy Complications (Procedure); Questionnaire Administration (Other)

Phase: Phase 2

Status: Recruiting

Sponsored by: OHSU Knight Cancer Institute

Official(s) and/or principal investigator(s):
Kathleen Kemmer, Principal Investigator, Affiliation: OHSU Knight Cancer Institute

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.

Clinical Details

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

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: Decrease in symptoms of vaginal dryness and dyspareunia

Secondary outcome:

Decrease in symptoms of vaginal itching

Total vaginal index score (dryness, itching, and dyspareunia)

Number of patients experiencing toxicities

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Adult women (both pre-menopausal and post-menopausal women are eligible) and with a

history of breast cancer or with an increased risk for breast cancer on current treatment with tamoxifen or an aromatase inhibitor with the presence of vaginal dryness or dyspareunia of sufficient severity to make the subject patient desire therapeutic intervention

- Vaginal dryness or dyspareunia must be present for at least two months prior to study

entry

- Subjects must be on current treatment with tamoxifen or an aromatase inhibitor for at

least two months prior to study enrollment (defined as the date of consent) and should not be planning to discontinue treatment or to change dose or type of endocrine treatment during the duration of the study

- Subjects must agree to not use any over-the-counter or prescription vaginal

preparations (lubricants, creams, gels, ointments, solutions) during the four weeks of treatment with topical fluocinonide cream

- Subjects must agree to not use any medications, products, or preparations known to

contain estrogen during the four weeks of treatment with topical fluocinonide cream

- Eastern Cooperative Oncology Group (ECOG) performance status =< 2

- Subjects must have ability to read, comprehend, and complete patient questionnaires

independently or with assistance

- Subjects must sign informed consent

- Subjects must agree to read patient instructions regarding use of barrier

contraceptive devices while on treatment with fluocinonide cream in the informed consent Exclusion Criteria:

- Use of any vaginal preparations within one week prior to study enrollment (exception:

subjects currently using a vaginal preparation can enroll after discontinuing treatment for 7 days)

- Use of any estrogen containing medications, products, or preparations

- Use of any systemic oral or parenteral steroid containing medications is not

permitted; use of "High Daily Dose" inhaled/intranasal corticosteroids is not permitted; use inhaled/intranasal corticosteroid preparations at dosing levels less than "High Daily Dose" is permitted

- Current or past treatment with fluocinonide cream for vaginal dryness, itching, or

dyspareunia

- Subject reported symptoms of vaginal infection with significant vaginal discharge or

odor

- Known current vaginal infection

- Known vaginal pathology other than vaginal atrophy that could explain vaginal

symptoms

- Known intolerance of topical steroid preparations

- Pregnant or lactating women (to be obtained via subject report only)

- Known diagnoses of diabetes mellitus, adrenal insufficiency (Addison's disease), or

Cushing's syndrome

- No prior chemotherapeutic treatment for any malignancy other than breast cancer

Locations and Contacts

OHSU Knight Cancer Institute, Portland, Oregon 97239, United States; Recruiting
Kathleen A. Kemmer, Phone: 503-494-8534, Email: kemmerk@ohsu.edu
Kathleen A. Kemmer, Principal Investigator
Additional Information

Starting date: September 2011
Last updated: March 25, 2015

Page last updated: August 23, 2015

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