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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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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 patients on adjuvant 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 patients on adjuvant endocrine
therapy. Estimates of decrease will be obtained utilizing patient survey instruments.

II. To explore toxicities reported by patients using fluocinonide 0.05% cream via vaginal
application.

III. 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.


Inclusion Criteria:



- Adult women >= 18 years of age (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 patient
desire therapeutic intervention

- Symptoms must be present for at least two months prior to study entry

- Patients must be on current treatment with tamoxifen citrate or an aromatase
inhibitor for at least two months prior to study entry and should not discontinue
treatment during the duration of the study

- Patients 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

- Patients 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

- Patients must have ability to complete patient questionnaires independently or with
assistance

- Patients must sign informed consent

- Patients must agree to read patient instructions regarding use of barrier
contraceptive devices while on treatment with fluocinonide cream on the patient
information sheet

Exclusion Criteria:

- Use of any vaginal preparations within one week prior to study entry (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 steroid containing medications (including inhaled
corticosteroids)

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

- Patient 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

- 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Decrease in symptoms of vaginal dryness and dyspareunia after 4 weeks of treatment

Outcome Description:

Decrease in symptoms of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to five (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints.

Outcome Time Frame:

Baseline, weekly until 28 days

Safety Issue:

No

Principal Investigator

Stephen Chui

Investigator Role:

Principal Investigator

Investigator Affiliation:

OHSU Knight Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

7265

NCT ID:

NCT01422408

Start Date:

August 2011

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms
  • Dyspareunia

Name

Location

OHSU Knight Cancer InstitutePortland, Oregon  97239