Non-Hormonal Vaginal Moisturizer in Hormone-Receptor Positive Postmenopausal Cancer Survivors Experiencing Estrogen Deprivation Symptoms on Vulvovaginal Health

Not Applicable

Completed

• Conditions: Breast Cancer; Endometrial Cancer
• Interventions: Other: HLA vaginal gel (HyaloGYN®),; Behavioral: questionnaires

• Registration Number: NCT01738152
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-28
• Study First Submitted QC: 2012-11-28
• Study First Posted: 2012-11-30
• Status Verified: 2021-07
• Primary Completion: 2021-07-21
• Study Completion: 2021-07-21
• Last Update Submitted: 2021-07-22
• Last Update Posted: 2021-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 106

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HLA treatment	HLA vaginal gel (HyaloGYN®),	This is a single arm prospective longitudinal clinical trial investigating the feasibility of a hyaluronic acid (HLA) vaginal gel (HyaloGYN®; Cebert Pharmaceuticals, Inc.; Birmingham, Alabama) to improve estrogen deprivation vaginal and vulvar health symptoms in post-menopausal women with a history of hormone-receptor positive cancer with estrogen deprivation symptoms of vaginal dryness and discomfort.
HLA treatment	questionnaires	This is a single arm prospective longitudinal clinical trial investigating the feasibility of a hyaluronic acid (HLA) vaginal gel (HyaloGYN®; Cebert Pharmaceuticals, Inc.; Birmingham, Alabama) to improve estrogen deprivation vaginal and vulvar health symptoms in post-menopausal women with a history of hormone-receptor positive cancer with estrogen deprivation symptoms of vaginal dryness and discomfort.

Primary Outcome Measures

Name	Time	Method
investigate feasibility of conducting a 12-week HLA treatment regimen	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 Outcome Measures

Name	Time	Method
Vaginal Assessment Composite Score [VAS]	12 weeks post-HLA treatment initiation	as measured by the Vaginal Assessment Composite Score \[VAS\], vaginal pH and epithelial atrophy)
Vulvar Assessment Composite Score [VuAS]	12 weeks post-HLA treatment initiation	(as measured by the Vulvar Assessment Composite Score \[VuAS\], vulvar atrophy, and vulvar/vestibular irritation)

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States