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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Breast Cancer, Endometrial Cancer

Intervention / Treatment
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* Other: HLA vaginal gel (HyaloGYN®),
* Behavioral: questionnaires


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HLA treatment<br>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. | Other: HLA vaginal gel (HyaloGYN®),<br>* Each participant will receive a HLA vaginal gel (HyaloGYN®), which is an over-the-counter, colorless gel to be administered for hydration and lubrication of the vaginal epithelium for women suffering dryness,as well as to the vulva for women suffering from vulvar symptoms. All participants will be instructed to insert the HLA gel into the vagina (with applicator) daily for the first 2 weeks, and then 3 times per week for 10 weeks. The women with vulvar symptoms at the baseline assessment will additionally be instructed to apply the HLA gel onto the vulva (manually) daily for the first 2 weeks, and then 3 times per week for 10 weeks. The participants will be assessed at 12 weeks. Participants receiving benefit from HyaloGYN®, as operationalized by improvement in both vaginal pH and VAS score will continue using the product 3 times per week for another 12 weeks and will receive a final vulvovaginal assessment at 24 weeks post-HLA treatment initiation.<br>Behavioral: questionnaires<br>* Assessment Form as part of routine clinical care. Participants will be asked to complete questionnaires at the baseline initial evaluation, 4-6 weeks, 12-14 weeks, and 22-24 weeks. The study information collected will be found in the standardized Clinical Assessment Form that patients complete as part of routine clinical care, along with an additional survey pertinent to the aims of the study. At 24 weeks, participants will complete an additional questionnaire that will ask questions regarding their experience with HyaloGYN® and their acceptability of and satisfaction with the product. Study participants must see the FSM NP or GYN clinician for the targeted exams at the study follow-up time points (4-6 weeks, 12-14 weeks, 22-24 weeks). PhD follow-up visits can be based upon the treatment plan of the patient. The study questionnaires and moisturizer diaries will be completed and collected during follow-up appointments with the GYN clinician or FSM NP.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| investigate feasibility of conducting a 12-week HLA treatment regimen | 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). | 12-week | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HYALOGYN VAGINAL GEL, vaginal dryness, 12-232