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

NCT01738152 | Completed

• 1 other identifier: 12-232
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Endometrial Cancer

Keywords

HYALOGYN VAGINAL GEL; vaginal dryness; 12-232

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Vaginal Assessment Composite Score [VAS]

  12 weeks post-HLA treatment initiation

• Vulvar Assessment Composite Score [VuAS]

  12 weeks post-HLA treatment initiation

Study Arms (1)

HLA treatment

EXPERIMENTAL

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®),; Behavioral: questionnaires

Interventions

HLA vaginal gel (HyaloGYN®), OTHER

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.

HLA treatment

questionnaires BEHAVIORAL

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.

HLA treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms; Endometrial Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jeanne Carter, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2012
• First Posted: November 30, 2012
• Study Start: November 1, 2012
• Primary Completion: July 21, 2021
• Study Completion: July 21, 2021
• Last Updated: July 23, 2021

Record last verified: 2021-07

Locations

US (1)