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
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.
Study Type
Interventional
Primary Outcome
investigate feasibility of conducting a 12-week HLA treatment regimen
Secondary Outcome
Vaginal Assessment Composite Score [VAS]
Condition
Breast Cancer
Intervention
HLA vaginal gel (HyaloGYN®),
Study Arms / Comparison Groups
HLA treatment
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
106
Start Date
November 2012
Completion Date
November 2020
Primary Completion Date
November 2020
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)
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Jeanne Carter, PhD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01738152
Organization ID
12-232
Responsible Party
Sponsor
Study Sponsor
Memorial Sloan Kettering Cancer Center
Study Sponsor
Jeanne Carter, PhD, Principal Investigator, Memorial Sloan Kettering Cancer Center
Verification Date
December 2019