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

Primary Purpose

Breast Cancer, Endometrial Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HLA vaginal gel (HyaloGYN®),
questionnaires
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring HYALOGYN VAGINAL GEL, vaginal dryness, 12-232

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HLA treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Vaginal Assessment Composite Score [VAS]
as measured by the Vaginal Assessment Composite Score [VAS], vaginal pH and epithelial atrophy)
Vulvar Assessment Composite Score [VuAS]
(as measured by the Vulvar Assessment Composite Score [VuAS], vulvar atrophy, and vulvar/vestibular irritation)

Full Information

First Posted
November 28, 2012
Last Updated
July 22, 2021
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01738152
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
July 21, 2021 (Actual)
Study Completion Date
July 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Endometrial Cancer
Keywords
HYALOGYN VAGINAL GEL, vaginal dryness, 12-232

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HLA treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
HLA vaginal gel (HyaloGYN®),
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
questionnaires
Intervention Description
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.
Primary Outcome Measure Information:
Title
investigate feasibility of conducting a 12-week HLA treatment regimen
Description
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).
Time Frame
12-week
Secondary Outcome Measure Information:
Title
Vaginal Assessment Composite Score [VAS]
Description
as measured by the Vaginal Assessment Composite Score [VAS], vaginal pH and epithelial atrophy)
Time Frame
12 weeks post-HLA treatment initiation
Title
Vulvar Assessment Composite Score [VuAS]
Description
(as measured by the Vulvar Assessment Composite Score [VuAS], vulvar atrophy, and vulvar/vestibular irritation)
Time Frame
12 weeks post-HLA treatment initiation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeanne Carter, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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