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

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OHSU Knight Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Fluocinonide

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