Fluocinonide Cream in Treating Symptoms of Vaginal Dryness and Painful Sexual Intercourse In Patients With Breast Cancer Undergoing Hormone Therapy
Condition: Breast Carcinoma
MeSH terms: Breast Neoplasms
Intervention: Fluocinonide Cream; Management of Therapy Complications; Questionnaire Administration
Intervention description: Given topically; Receive fluocinonide cream; Ancillary studies
Intervention MeSH terms: Fluocinonide
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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