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

NCT ID: NCT01422408

Last Updated: 2017-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2015-10-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Supportive care (fluocinonide cream)

Patients apply topical fluocinonide cream BID in weeks 1-2 and QD in weeks 3-4.

Group Type: EXPERIMENTAL

Fluocinonide Cream

Intervention Type: DRUG

Given topically

Management of Therapy Complications

Intervention Type: PROCEDURE

Receive fluocinonide cream

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Fluocinonide Cream

Given topically

Intervention Type: DRUG

Management of Therapy Complications

Receive fluocinonide cream

Intervention Type: PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

fluocinonide; Lidex; Vanos; complications of therapy, management of

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Kathleen Kemmer

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathleen Kemmer

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

OHSU Knight Cancer Institute

Portland, Oregon, United States

Countries

United States

Other Identifiers

NCI-2011-01234

Identifier Type: REGISTRY

Identifier Source: secondary_id

CPC-11028-L

Identifier Type: OTHER

Identifier Source: secondary_id

7265

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA69533OD

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

P30CA069533

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00007265

Identifier Type: -

Identifier Source: org_study_id