Recruiting NCT07042581
A Study of Revaree Plus in People With Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Revaree Plus.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Stage 0 Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of Revaree Plus in Women With Breast Cancer
Overview
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
- Drug Revaree Plus
Revaree Plus is a hyaluronic acid vaginal suppository
Primary outcome measures
- Change in Vaginal Assessment Scale from baseline to 8 weeks [Time frame: 8 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 7 centers
- Memorial Sloan Kettering Basking Ridge (Consent Only) — Basking Ridge
- Memorial Sloan Kettering Monmouth (Consent Only) — Middletown
- Memorial Sloan Kettering Bergen (Consent Only) — Montvale
- Memorial Sloan Kettering Cancer Center Suffolk-Commack (Consent Only) — Commack
- Memorial Sloan Kettering Westchester (Consent Only) — Harrison
- Memorial Sloan Kettering Cancer Center — New York
- Memorial Sloan Kettering Nassau (Consent Only) — Uniondale
Identifiers
NCT: NCT07042581 · 24-374