This phase IV trial tests how well giving a hyaluronic acid vaginal suppository (Revaree Plus) works to improve vaginal health in women receiving an aromatase inhibitor or tamoxifen for stage 0-3 hormone receptor positive breast cancer. Breast cancer treatments can have significant impacts on vulvovaginal health and sexual wellbeing, either by inducing menopause or worsening menopausal symptoms. Non-hormonal vaginal suppositories containing hyaluronic acid work by increasing hydration of the vaginal tissue and therefore exerting a moisturizing effect on the skin. Ravaree Plus may be effective in improving vaginal health in women receiving an aromatase inhibitor or tamoxifen for stage 0-3 hormone receptor positive breast cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT07042581.
Locations matching your search criteria
United States
New York
New York
Memorial Sloan Kettering Cancer CenterStatus: Active
Contact: Shari Beth Goldfarb
Phone: 646-888-5080
PRIMARY OBJECTIVE:
I. To evaluate the effectiveness of Revaree Plus treatment by determining whether vaginal health (as measured by the Vaginal Assessment Scale) improves from baseline to 8 weeks post-Revaree Plus treatment in women with breast cancer who have complete their primary breast cancer treatment (surgery, chemotherapy, or radiation).
SECONDARY OBJECTIVES:
I. To evaluate the effectiveness of Revaree Plus treatment on vulvar health from baseline to 8 weeks using the Vulvar Assessment Scale (VuAS).
II. To evaluate if the effects of Revaree Plus treatment on vaginal and vulvar health are sustained over time from baseline to week 12.
III. To assess potential benefits of Revaree Plus treatment to participants’ sexual function using patient-reported outcomes (PROs) specific to sexual function (Patient Reported Outcome Measurement Information System [PROMIS] and Female Sexual Function Index [FSFI] sexual function items) at baseline, week 8 and week 12.
IV. To assess objectively vaginal and vulvar symptoms as measured by the GYN Checklist/Gynecological Evaluation for patients who are being seen either the Gynecology or Female Sexual Medicine clinics and completing pelvic exams.
V. To compare the Menopausal Symptom Check List (MSCL), PROMIS, Vulvovaginal Symptom Questionnaire (VSQ), VuAS, and VAS scores of patients followed by Gynecology service to those only seen in the Breast Medicine Service.
VI. To evaluate patient satisfaction with Revaree Plus using the Patient Satisfaction Questionnaire at 12 weeks.
OUTLINE:
Patients insert the Revaree Plus suppository vaginally every 2-3 days for 12 weeks in the absence of unacceptable toxicity. Patients may undergo pelvic exam on study.
Trial PhasePhase IV
Trial Typesupportive care
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorShari Beth Goldfarb