Trial record 5 of 9 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.
Verified October 2012 by OHSU Knight Cancer Institute
Sponsor:
OHSU Knight Cancer Institute
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT01422408
First received: August 22, 2011
Last updated: February 28, 2013
Last verified: October 2012
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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:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Fluocinonide
U.S. FDA Resources
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: | May 2013 (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:
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
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: | February 28, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Dyspareunia Breast Neoplasms 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 Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Anti-Allergic Agents Therapeutic Uses Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on June 18, 2013