Clinical trial NCT01422408: Fluocinonide Cream in Treating Symptoms of Vaginal Dryness and Painful Sexual Intercourse In Patients With Breast Cancer Undergoing Hormone Therapy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Carcinoma
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-08-24
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in Symptom Scores of Vaginal Dryness
timeFrame: Baseline and 4 weeks
measure: Change in Symptom Scores of Dyspareunia
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Change in Symptom Scores of Vaginal Itching
timeFrame: Baseline and 4 weeks
measure: Change in Total Vaginal Index Score.
timeFrame: Baseline and 4 weeks
measure: Number of Patients Experiencing Toxicities
timeFrame: Over 4 weeks
measure: Change in Vaginal Dryness Symptom Scores by Age Characteristics
timeFrame: Baseline and 4 weeks
measure: Change in Dyspareunia Symptom Scores by Age Characteristics
timeFrame: Baseline and 4 weeks
measure: Change in Vaginal Itching Symptom Scores by Age Characteristics
timeFrame: Baseline and 4 weeks
measure: Change in Vaginal Dryness Symptom Scores by Menopause Status Characteristics
timeFrame: Baseline and 4 weeks
measure: Change in Dyspareunia Symptom Scores by Menopause Status Characteristics
timeFrame: Baseline and 4 weeks
measure: Change in Vaginal Itching Symptom Scores by Menopause Status Characteristics
timeFrame: Baseline and 4 weeks
measure: Change in Vaginal Dryness Symptom Scores by Current Endocrine Therapy Characteristics
timeFrame: Baseline and 4 weeks
measure: Change in Dyspareunia Symptom Scores by Current Endocrine Therapy Characteristics
timeFrame: Baseline and 4 weeks
measure: Change in Vaginal Itching Symptom Scores by Current Endocrine Therapy Characteristics
timeFrame: Baseline and 4 weeks
measure: Change in Vaginal Dryness Symptom Scores by Prior Cytotoxic Therapy Characteristics
timeFrame: Baseline and 4 weeks
measure: Change in Dyspareunia Symptom Scores by Prior Cytotoxic Therapy Characteristics
timeFrame: Baseline and 4 weeks
measure: Change in Vaginal Itching Symptom Scores by Prior Cytotoxic Therapy Characteristics
timeFrame: Baseline and 4 weeks
measure: Change in Vaginal Dryness Symptom Scores by Indication for Endocrine Therapy Characteristics
timeFrame: Baseline and 4 weeks
measure: Change in Dyspareunia Symptom Scores by Indication for Endocrine Therapy Characteristics
timeFrame: Baseline and 4 weeks
measure: Change in Vaginal Itching Symptom Scores by Indication for Endocrine Therapy Characteristics
timeFrame: Baseline and 4 weeks
measure: Change in Vaginal Dryness Symptom Scores by Patient Reported Compliance Characteristics
timeFrame: Baseline and 4 weeks
measure: Change in Dyspareunia Symptom Scores by Patient Reported Compliance Characteristics
timeFrame: Baseline and 4 weeks
measure: Change in Vaginal Itching Symptom Scores by Patient Reported Compliance Characteristics
timeFrame: Baseline and 4 weeks
measure: Change in Vaginal Dryness Symptom Scores by Tube Weight Based Compliance Characteristics
timeFrame: Baseline and 4 weeks
measure: Change in Dyspareunia Symptom Scores by Tube Weight Based Compliance Characteristics
timeFrame: Baseline and 4 weeks
measure: Change in Vaginal Itching Symptom Scores by Tube Weight Based Compliance Characteristics
timeFrame: Baseline and 4 weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Kathleen Kemmer
role: PRINCIPAL_INVESTIGATOR
References: