Clinical trial NCT01738152: Non-Hormonal Vaginal Moisturizer in Hormone-Receptor Positive Postmenopausal Cancer Survivors Experiencing Estrogen Deprivation Symptoms on Vulvovaginal Health
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Endometrial Cancer
Keywords: HYALOGYN VAGINAL GEL
vaginal dryness
12-232
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2012-11-30
Enrollment: 106
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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
* Rendered post-menopausal with the use of LHRH agonist
* Patients who are new visits to Female Sexual Medicine Program or patients are not consistently using any vulvovaginal health promotion strategies (e.g., pelvic floor exercises, dilator therapy, moisturizers) recommended by the Female Sexual Medicine Program Reporting being bothered by vulvovaginal symptoms of estrogen deprivation (i.e., vulvovaginal dryness or discomfort \[pain with intercourse or examination\])
* Without history of other cancers (excluding non-melanoma skin cancer)
* Women at least 18 years of age
* Able to read and speak English
* Able to participate in the informed consent process

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)

Primary outcomes:
measure: investigate feasibility of conducting a 12-week HLA treatment regimen
timeFrame: 12-week
Secondary outcomes:
measure: Vaginal Assessment Composite Score [VAS]
timeFrame: 12 weeks post-HLA treatment initiation
measure: Vulvar Assessment Composite Score [VuAS]
timeFrame: 12 weeks post-HLA treatment initiation
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jeanne Carter, PhD
role: PRINCIPAL_INVESTIGATOR
References: