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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01738152
First received: November 28, 2012
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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 vaginal health.

This study aims to look at whether or not it is effective in women with a history of hormone receptor positive cancer and experiencing vaginal symptoms of estrogen deprivation following their breast and endometrial cancer treatment.


Condition Intervention
Breast Cancer
Endometrial Cancer
Other: HLA vaginal gel (HyaloGYN®),
Behavioral: questionnaires

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • investigate feasibility of conducting a 12-week HLA treatment regimen [ Time Frame: 12-week ] [ Designated as safety issue: No ]
    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 outcome assessments).


Secondary Outcome Measures:
  • evaluate the effectiveness of Non-hormonal vaginal gel containing hyaluronic acid (HLA)treatment [ Time Frame: 12 weeks post-HLA treatment initiation ] [ Designated as safety issue: No ]
    as measured by the Vaginal Assessment Composite Score [VAS], vaginal pH and epithelial atrophy)


Estimated Enrollment: 60
Study Start Date: November 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HLA treatment
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 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®),
Each participant will receive a HLA vaginal gel (HyaloGYN®), which is an over-the-counter, colorless gel to be administered as a vaginal gel for hydration and lubrication of the vaginal epithelium for women suffering dryness. 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.Participants will also be asked to keep a moisturizer diary. In it they will record the date and time the gel is used. The initial PhD/NP visit and subsequent NP visits, including completion of the Clinical Assessment Form and the pelvic exam performed by the NP are all part of the standard treatment plan that all patients receive at the Female Sexual Medicine Program. PhD follow-up visits can be based upon the treatment plan of the patient and is not always necessary within the specified study time points.
Behavioral: questionnaires
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 NP 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 (Appendix II-Follow-Up and Appendix IV) and moisturizer diaries (Appendix III) will be completed and collected during the NP follow-up appointments.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of breast cancer or endometrial cancer confirmed at MSKCC
  • 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 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 who have previously seen the PhD but have never had a pelvic exam by the Female Sexual Medicine NP and are not consistently using any vaginal health promotion strategies (e.g., pelvic floor exercises, dilator therapy, moisturizers) Reporting being bothered by vaginal symptoms of estrogen deprivation (i.e., vaginal 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01738152

Contacts
Contact: Jeanne Carter, Ph.D. 646-888-5076
Contact: Maura Dickler, MD 646-888-5456

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Jeanne Carter, PhD    646-888-5076      
Contact: Maura Dickler, MD    646-888-5456      
Principal Investigator: Jeanne Carter, PhD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Jeanne Carter, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01738152     History of Changes
Other Study ID Numbers: 12-232
Study First Received: November 28, 2012
Last Updated: August 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
HYALOGYN VAGINAL GEL
vaginal dryness
12-232

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Estrogens
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014