A Single-Arm Clinical Trial Investigating the Feasibility of a Non-Hormonal Vaginal Moisturizer in Hormone-Receptor Positive Postmenopausal Cancer Survivors Experiencing Estrogen Deprivation Symptoms on Vulvovaginal Health

Memorial Sloan Kettering Cancer Center1 site in 1 country106 target enrollmentNovember 2012

ConditionsBreast Cancer Endometrial Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 106
Locations: 1
Primary Endpoint: investigate feasibility of conducting a 12-week HLA treatment regimen
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to see whether it is feasible to conduct a study to determine if the use of hyaluronic acid (HLA) vaginal gel (HyaloGYN®) improves vulvovaginal health.

This study aims to look at whether or not HyaloGYN® is effective in women with a history of hormone receptor positive cancer and experiencing vaginal and/or vulvar symptoms of estrogen deprivation following their breast and endometrial cancer treatment.

Registry

clinicaltrials.gov

Start Date

November 2012

End Date

July 21, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•History of breast cancer or endometrial cancer confirmed at MSKCC or outside pathology report
•Breast cancer patients must be at least 3 months post-active treatment (including chemotherapy, radiation therapy, endocrine therapy, and/or maintenance therapy), but not greater than 5 years post-active treatment (exception: AIs are required, and monoclonal antibodies are allowed)
•Breast cancer patients must be currently on adjuvant aromatase inhibitors
•Endometrial cancer patients must be at least 3 months post-active chemotherapy and/or maintenance therapy treatment but not greater than 5 years post-active chemotherapy and/or maintenance therapy treatment. They must be at least 4 weeks post-radiation therapy (EBRT or IVRT) but not greater than 5 years post-radiation therapy.
•Endometrial cancer patients must have underwent surgical treatment (total abdominal hysterectomy (\[TAH\]/BSO)) and radiation therapy (external beam radiation therapy \[EBRT\] or IVRT)
•Currently have no clinical evidence of disease
•Menopausal at study entry as described by:
•Surgical menopause (TAH/BSO), or
•Age ≥ 50 years and cessation of menstruation for at least 1 year, or
•Age \<50 years and cessation of menstruation for at least 1 year with estradiol level in post-menopausal range, or

Exclusion Criteria

•Inability to provide informed consent
•Vaginal bleeding of unknown etiology within 12 months of study entry
•Currently taking hormone replacement therapy \[local or systemic\] (Patients must discontinue for 2 weeks in order to be eligible prior to study enrollment)

Outcomes

Primary Outcomes

investigate feasibility of conducting a 12-week HLA treatment regimen

Time Frame: 12-week

a 12-week HLA treatment regimen, as defined by the percentage of women who are evaluable at the 12-week assessment (i.e., women who have completed both baseline and 12-week vaginal and vulvar outcome assessments).

Secondary Outcomes

Vaginal Assessment Composite Score [VAS](12 weeks post-HLA treatment initiation)
Vulvar Assessment Composite Score [VuAS](12 weeks post-HLA treatment initiation)