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Clinical Trial REVITALIZE Begins Enrollment to Test Laser Therapy for Vaginal Dryness in Breast Cancer Survivors

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Alliance for Clinical Trials in Oncology Opens REVITALIZE Study for Breast Cancer Survivors

The Alliance for Clinical Trials in Oncology has opened enrollment for a clinical trial, designated REVITALIZE (Alliance A221801), to evaluate a treatment for vaginal dryness in breast cancer survivors. The study will test vaginal fractional CO₂ laser therapy against a placebo procedure in approximately 250 participants.

The trial is a randomized, placebo-controlled study supported in part by a grant from the National Cancer Institute.

Study Design & Participant Journey

  • Target Population: Approximately 250 women with a history of breast cancer who experience moderate to severe vaginal dryness.
  • Interventions: Participants will be randomly assigned to receive either vaginal fractional CO₂ laser therapy or a placebo procedure.
  • Treatment Schedule: The assigned procedure will be administered every six weeks for a total of three sessions.
  • Follow-up: Participants will be monitored for up to 24 months after the treatment period concludes.
  • Crossover Option: Individuals assigned to the placebo group will have the option to receive the laser therapy after completing the three placebo sessions.

What the Trial Will Measure

The trial has defined primary and secondary objectives to assess the therapy's effectiveness and impact.

  • Primary Objective: To determine if laser therapy improves the severity of vaginal dryness, as measured by an 11-point patient-reported scale.
  • Secondary Objectives: To evaluate vaginal discomfort during sexual activity, overall quality of life, and the incidence of treatment-related side effects.

Background & Unmet Need

Vaginal dryness and related symptoms are reported as common side effects for breast cancer survivors, particularly among postmenopausal women and those receiving long-term endocrine therapies such as aromatase inhibitors or tamoxifen. Current treatment options are described as limited, especially for patients who cannot use estrogen-based therapies. High-quality randomized data on laser-based therapies for this specific population are noted as limited.

About the Procedure: Vaginal CO₂ laser therapy is a minimally invasive outpatient procedure. It involves inserting a probe into the vagina, which emits pulses of light energy. This process creates micro-injuries in the tissue, a mechanism intended to stimulate local blood flow and collagen production. The procedure typically lasts about 15 minutes.

Leadership & Significance

The study is chaired by Maryam Lustberg, MD, MPH, Professor of Medical Oncology at Yale University Comprehensive Cancer Center. It is co-led by Don Dizon, MD, the Jane F. Desforges, M.D., Chair in Hematology and Oncology at Tufts University School of Medicine, and Allison Quick, MD, Associate Professor of Radiation Oncology at The Ohio State University Comprehensive Cancer Center.

Dr. Lustberg stated the study addresses an unmet supportive care need for breast cancer survivors. "By using a randomized, placebo-controlled design and patient-reported outcomes, the trial aims to provide evidence to guide patients and clinicians on managing long-term genitourinary side effects of breast cancer treatment."

She also noted that supportive care research is a growing priority in oncology and that findings from REVITALIZE may inform evidence-based recommendations and influence clinical guidelines.