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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


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Endometrial Cancer

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Trial Information

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


Inclusion Criteria:



- History of breast cancer or endometrial cancer confirmed at MSKCC

- Have completed primary treatment (surgery, radiation therapy, or chemotherapy), with
the exception of endocrine therapy and Trastuzumab

- Breast cancer patients must be currently on adjuvant aromatase inhibitors

- Endometrial cancer patients must have underwent surgical treatment (total abdominal
hysterectomy ([TAH]/BSO)) and radiation therapy (external beam radiation therapy
[EBRT] or IVRT)

- At least 3 months post-treatment but not greater than 5 years post-treatment
(exception: AIs are allowed)

- 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 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 4 weeks in order to be eligible prior to study enrollment)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

investigate feasibility of conducting a 12-week HLA treatment regimen

Outcome 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 outcome assessments).

Outcome Time Frame:

12-week

Safety Issue:

No

Principal Investigator

Jeanne Carter, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

12-232

NCT ID:

NCT01738152

Start Date:

November 2012

Completion Date:

November 2014

Related Keywords:

  • Breast Cancer
  • Endometrial Cancer
  • HYALOGYN VAGINAL GEL
  • vaginal dryness
  • 12-232
  • Breast Neoplasms
  • Endometrial Neoplasms
  • Adenoma

Name

Location

Memorial Sloan Kettering Cancer Center New York, New York  10021