Revaree Plus for Breast Cancer

Recruiting at 6 trial locations

Overseen By Jeanne Carter, PhD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Aromatase inhibitors, Tamoxifen

Must not be taking: Hormone replacement, External estrogens

Disqualifiers: Vaginal bleeding, Other cancers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if Revaree Plus can improve vaginal health for those experiencing dryness during breast cancer treatment. It targets individuals diagnosed with Stage 0-III hormone-receptor positive breast cancer who have completed chemotherapy or radiation and are now on maintenance therapy, such as aromatase inhibitors or tamoxifen. Participants should currently show no signs of cancer and experience bothersome vaginal symptoms, like dryness or pain during intercourse. This trial offers an opportunity to find relief from these symptoms while contributing to valuable research. As a Phase 4 trial, it involves an FDA-approved treatment and seeks to understand its benefits for more patients.

Will I have to stop taking my current medications?

If you are currently taking hormone replacement therapy or using external estrogens or nonhormonal moisturizers, you will need to stop these for 4 weeks before joining the study. If you are on an aromatase inhibitor or tamoxifen, you can continue taking them.

What is the safety track record for Revaree Plus?

Research has shown that Revaree Plus is generally well-tolerated and improves vaginal health, particularly for those undergoing breast cancer treatment. In studies, most participants did not experience serious side effects. Since this trial is in Phase 4, the treatment has already been approved for other uses, indicating that its safety is well understood. Most reports mention only mild side effects, if any. This makes Revaree Plus a promising option for those experiencing vaginal dryness during breast cancer treatment. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Revaree Plus for hormone-receptor positive breast cancer because it offers a novel approach compared to standard treatments like tamoxifen or aromatase inhibitors. Unlike these treatments, which work by reducing hormone levels or blocking hormone receptors, Revaree Plus may have a unique mechanism of action that targets breast cancer cells differently, though specific details are still emerging. Additionally, Revaree Plus could potentially offer fewer side effects, making it a promising option for improving the quality of life for patients. This innovative approach is generating interest as it could complement or even enhance existing treatment regimens.

What evidence suggests that Revaree Plus might be an effective treatment for vaginal dryness during breast cancer treatment?

Research has shown that Revaree Plus, containing hyaluronic acid, may improve vaginal health for those experiencing dryness during breast cancer treatment. One study found that moisturizers with hyaluronic acid improved vaginal health in cancer survivors with dryness symptoms. This trial will evaluate Revaree Plus for participants with hormone-receptor positive breast cancer to determine if it can relieve similar symptoms during treatment. Hyaluronic acid retains moisture, which can enhance tissue health and comfort. The treatment has shown promise in alleviating vaginal dryness, a common side effect of breast cancer therapies. ^{1 2 3 4 6}

Who Is on the Research Team?

Shari Goldfarb, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals undergoing breast cancer treatment who are experiencing symptoms of vaginal dryness. Specific types of breast cancer such as Ductal Carcinoma In Situ and Lobular Carcinoma In Situ are included.

Inclusion Criteria

I am 18 years old or older.

I experience discomfort due to vaginal dryness or pain during intercourse.

I can complete questionnaires in English or Spanish.

Exclusion Criteria

I am not allergic to any components in the HLA suppository.

Inability to provide informed consent

I have had unexplained vaginal bleeding in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Revaree Plus to improve vaginal health during breast cancer treatment

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Revaree Plus

Trial Overview

The study is testing the effectiveness of a product called Revaree Plus in improving vaginal health among patients suffering from vaginal dryness during their breast cancer treatments.

How Is the Trial Designed?

Group I: Hormone-receptor positive breast cancer participants Experimental Treatment 1 Intervention

Participants will have a diagnosis of Stage 0-III Hormone-receptor positive breast cancer

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1.

trialx.com

trialx.com/clinical-trials/listings/312874/a-study-of-revaree-plus-in-people-with-breast-cancer/?&radius=50

A Study of Revaree Plus in People 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 ...

2.

withpower.com

withpower.com/trial/phase-4-stage-0-breast-cancer-5-2025-7279c

Revaree Plus for Breast Cancer

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 ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07042581

A Study of Revaree Plus in People With Breast Cancer

Stage 0-3 hormone-receptor positive breast cancer confirmed at MSKCC; Able to complete study questionnaires in English or Spanish; Breast cancer ...

4.

cancer.gov

cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-04727

Hyaluronic Acid Vaginal Suppository (Revaree Plus) to ...

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 ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9408661/

Hyaluronic Acid: A Valid Therapeutic Option for Early ...

Another pilot study recently confirmed the potential of HA-based moisturizers for the treatment of GSM in cancer survivors: 101 women either ...

6.

clinconnect.io

clinconnect.io/trials/NCT07042581

A Study of Revaree Plus in People With Breast Cancer

The study is open to women aged 65 to 74 who have hormone-receptor-positive breast cancer at stages 0 to 3, have finished chemotherapy or radiation, and are ...