Trial record 6 of 10 for:    Open Studies | "Dyspareunia"

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 March 2015 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: March 25, 2015
Last verified: March 2015
  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 Carcinoma
Drug: Fluocinonide Cream
Procedure: Management of Therapy Complications
Other: Questionnaire Administration
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 [ Time Frame: After 4 weeks of treatment ] [ 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:
  • Decrease in symptoms of vaginal itching [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Estimates of decrease will be obtained utilizing patient survey instruments. Vaginal itching will be graded on an ordinal scale of zero to five (none, mild, moderate, severe, and very severe, respectively). Generalized estimating equation (GEE) methods will be used to characterize changes in vaginal symptom scores over time. GEE methods permit the analysis of correlated normal and non-normal data (e.g., binary and ordinal data) and evaluation of fixed and time-dependent covariates (e.g., age, menopausal status, duration of vaginal symptoms, and type of adjuvant endocrine therapy).

  • Total vaginal index score (dryness, itching, and dyspareunia) [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
    GEE methods will be used to characterize changes in vaginal symptom scores over time. GEE methods permit the analysis of correlated normal and non-normal data (e.g., binary and ordinal data) and evaluation of fixed and time-dependent covariates (e.g., age, menopausal status, duration of vaginal symptoms, and type of adjuvant endocrine therapy).

  • Number of patients experiencing toxicities [ Time Frame: Over 4 weeks ] [ Designated as safety issue: Yes ]
    Toxicity data will be reported as descriptive data as the percentage of patients experiencing reported side effects. Toxicity and safety analyses will be conducted using the safety analysis set.


Estimated Enrollment: 35
Study Start Date: September 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: July 2015 (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.
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
Other: Questionnaire Administration
Ancillary studies

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  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: Kathleen A. Kemmer    503-494-8534    kemmerk@ohsu.edu   
Principal Investigator: Kathleen A. Kemmer         
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
Principal Investigator: Kathleen Kemmer 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, CPC-11028-L, 7265, P30CA69533OD
Study First Received: August 22, 2011
Last Updated: March 25, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Fluocinonide
Anti-Allergic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2015