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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by OHSU Knight Cancer Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT01422408
First received: August 22, 2011
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Breast Cancer
Other: questionnaire administration
Drug: fluocinonide cream
Procedure: management of therapy complications
Phase 2

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

Resource links provided by NLM:


Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • Decrease in symptoms of vaginal dryness and dyspareunia after 4 weeks of treatment [ Time Frame: Baseline, weekly until 28 days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Vaginal itching [ Time Frame: Baseline, at the end of 4 weeks ] [ Designated as safety issue: No ]
  • Total vaginal index score (dryness, itching, and dyspareunia) [ Time Frame: Baseline, at the end of 4 weeks ] [ Designated as safety issue: No ]
  • Number of patients experiencing toxicities [ Time Frame: Baseline, weekly for 28 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 31
Study Start Date: August 2011
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supportive care (fluocinonide cream)
Patients apply topical fluocinonide cream BID in weeks 1-2 and QD in weeks 3-4.
Other: questionnaire administration
Ancillary studies
Drug: fluocinonide cream
Given topically
Other Names:
  • fluocinonide
  • Lidex
  • Vanos
Procedure: management of therapy complications
Receive fluocinonide cream
Other Name: complications of therapy, management of

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01422408

Locations
United States, Oregon
OHSU Knight Cancer Institute Recruiting
Portland, Oregon, United States, 97239
Contact: Stephen Y. Chui       trials@ohsu.edu   
Contact: Kristine Lethert, M.D.       lethert@ohsu.edu   
Principal Investigator: Stephen Y. Chui         
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
Principal Investigator: Stephen Chui OHSU Knight Cancer Institute
  More Information

No publications provided

Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT01422408     History of Changes
Other Study ID Numbers: 7265, NCI-2011-01234
Study First Received: August 22, 2011
Last Updated: November 14, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Dyspareunia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Genital Diseases, Female
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Fluocinonide
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Allergic Agents

ClinicalTrials.gov processed this record on August 01, 2014