Breast Cancer, Hormone-receptor-positive Breast Cancer, Hormone Receptor Positive Breast Carcinoma, Hormone Receptor Positive Malignant Neoplasm of Breast, Stage 0 Breast Cancer, Stage 0 Breast Carcinoma, Stage I Breast Cancer, Stage II Breast Cancer, Stage II Breast Carcinoma, Stage III Breast Cancer, Stage III Breast Carcinoma
Conditions
Keywords
Breast Cancer, Stage 0 Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer, Stage 0 hormone receptor positive breast cancer, Stage I hormone receptor positive breast cancer, Stage II hormone receptor positive breast cancer, Stage III hormone receptor positive breast cancer, Revaree, 24-374, Memorial Sloan Kettering Cancer Center
Brief summary
The purpose of this study is to find out whether Revaree Plus is effective at improving vaginal health for people who are having symptoms of vaginal dryness during breast cancer treatment.
Interventions
DRUGRevaree Plus
Revaree Plus is a hyaluronic acid vaginal suppository
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥18 years of age at the time of signing informed consent. * Stage 0-3 hormone-receptor positive breast cancer confirmed at MSKCC * Able to complete study questionnaires in English or Spanish * Breast cancer patients must have completed primary therapy (surgery, and/or chemotherapy, and/or radiation therapy) or currently on maintenance therapy * Currently on an aromatase inhibitor or tamoxifen or Selective Estrogen Receptor Modulators (SERM) * Currently have no clinical evidence of disease * Reporting being bothered by vaginal symptoms of estrogen deprivation (i.e., vaginal dryness, dyspareunia, or discomfort \[pain with intercourse or examination\]) * A total score of 4 or greater in VAS * Without history of other cancers (excluding non-melanoma skin cancer) * Must sign an informed consent indicating that the participant understands the purpose of, and procedures required for the study and is willing to participate in the study
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) * Existing use of external estrogens or nonhormonal moisturizers (Patients must discontinue for 4 weeks in order to be eligible prior to study enrollment) * No known allergies to any ingredients in 10mg HLA suppository
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Vaginal Assessment Scale from baseline to 8 weeks | 8 weeks | The primary study objective is to evaluate whether vaginal health improves from baseline to 8 weeks of treatment with Revaree Plus as measured by the Vaginal Assessment Scale |
Countries
United States
Contacts
CONTACTShari Goldfarb, MD
CONTACTJeanne Carter, PhD
PRINCIPAL_INVESTIGATORShari Goldfarb, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed