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

Last updated: July 22, 2021
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Completed

Phase

N/A

Condition

Endometrial Cancer

Vaginal Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT01738152
12-232
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • History of breast cancer or endometrial cancer confirmed at MSKCC or outside pathologyreport
  • Breast cancer patients must be at least 3 months post-active treatment (includingchemotherapy, radiation therapy, endocrine therapy, and/or maintenance therapy), butnot greater than 5 years post-active treatment (exception: AIs are required, andmonoclonal 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/ormaintenance therapy treatment but not greater than 5 years post-active chemotherapyand/or maintenance therapy treatment. They must be at least 4 weeks post-radiationtherapy (EBRT or IVRT) but not greater than 5 years post-radiation therapy.
  • Endometrial cancer patients must have underwent surgical treatment (total abdominalhysterectomy ([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 levelin 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 notconsistently using any vulvovaginal health promotion strategies (e.g., pelvic floorexercises, dilator therapy, moisturizers) recommended by the Female Sexual MedicineProgram 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

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 mustdiscontinue for 2 weeks in order to be eligible prior to study enrollment)

Study Design

Total Participants: 106
Study Start date:
November 01, 2012
Estimated Completion Date:
July 21, 2021

Connect with a study center

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

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