RecruitingPhase 3NCT05379153

Testing Laser Therapy for Treatment of Vaginal Dryness in Survivors of Breast Cancer, The Revitalize Trial

The Revitalize Trial: Reducing Vaginal Atrophy With Fractional CO2 Laser for Breast Cancer Survivors


Sponsor

Alliance for Clinical Trials in Oncology

Enrollment

250 participants

Start Date

Apr 21, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This phase III trial compares the effect of vaginal fractional CO2 laser therapy to placebo for the treatment of vaginal dryness in breast cancer survivors with symptoms of genitourinary syndrome of menopause (GSM). Placebo therapy is an inactive treatment that is designed to mimic as closely as possible the active treatment being studied in a clinical trial. In this trial, patients will not be told whether they will be in the laser treatment group or the placebo group until 6-weeks after the third treatment visit (patient-blinded). At that point, patients who received placebo can elect to receive laser treatment similar to the other group. GSM is group of symptoms that affect the female genital and urinary systems and results from the lack of estrogen. Vaginal dryness can be commonly experienced with normal aging, with menopause, or come about from medications used to treat breast cancer such as chemotherapy or endocrine therapies like tamoxifen or aromatase inhibitors. Vaginal fractional CO2 laser therapy may help reduce vaginal dryness. compared to placebo.


Eligibility

Sex: FEMALEMin Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Laser Therapy, Quality of Life Assessment, and others for people with anatomic stage 0 breast cancer ajcc v8, anatomic stage i breast cancer ajcc v8, and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include women aged 22 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICELaser Therapy

Undergo vaginal fractional CO2 laser therapy

DEVICESham Intervention

Undergo placebo procedure

OTHERQuestionnaire Administration

Ancillary studies

OTHERQuality of Life Assessment

Ancillary studies


Locations(2)

Trinity Health IHA - Obstetrics and Gynecology West Arbor

Ann Arbor, Michigan, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT05379153


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