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

NCT01422408 | Completed Phase 2 Results DMC

• 6 other identifiers: IRB00007265NCI-2011-01234CPC-11028-L7265P30CA69533ODP30CA069533
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (2)

• Change in Symptom Scores of Vaginal Dryness

  Change in symptom scores 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 four (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 measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

  Baseline and 4 weeks

• Change in Symptom Scores of Dyspareunia

  Change in symptom scores 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 four (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 measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

  Baseline and 4 weeks

Secondary Outcomes (24)

• Change in Symptom Scores of Vaginal Itching

  Baseline and 4 weeks

• Change in Total Vaginal Index Score.

  Baseline and 4 weeks

• Number of Patients Experiencing Toxicities

  Over 4 weeks

• Change in Vaginal Dryness Symptom Scores by Age Characteristics

  Baseline and 4 weeks

• Change in Dyspareunia Symptom Scores by Age Characteristics

  Baseline and 4 weeks

Study Arms (1)

Supportive care (fluocinonide cream)

EXPERIMENTAL

Patients apply topical fluocinonide cream BID in weeks 1-2 and QD in weeks 3-4.

Drug: Fluocinonide Cream; Procedure: Management of Therapy Complications; Other: Questionnaire Administration

Interventions

Fluocinonide Cream DRUG

Given topically

Also known as: fluocinonide, Lidex, Vanos

Supportive care (fluocinonide cream)

Management of Therapy Complications PROCEDURE

Receive fluocinonide cream

Also known as: complications of therapy, management of

Supportive care (fluocinonide cream)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (fluocinonide cream)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fluocinonide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Fluocinolone Acetonide; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Limitations and Caveats

Original plan was to use GEE modeling for secondary analysis of primary endpoints. Missing data and small counts caused us to perform this analysis using other statistical methods. Data was categorized and tested using McNemar's Test for results

Results Point of Contact

• Title: Emile Latour
• Organization: Knight Cancer Institute, Oregon Health & Science University

latour@ohsu.edu

503-418-9601

Study Officials

• Kathleen Kemmer

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 22, 2011
• First Posted: August 24, 2011
• Study Start: September 1, 2011
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: August 9, 2017
• Results First Posted: August 9, 2017

Record last verified: 2017-07

Locations

US (1)