Many women who have completed breast cancer treatment continue to experience lingering side effects, including vaginal dryness and discomfort from medications like aromatase inhibitors or tamoxifen. These symptoms can affect intimacy, day-to-day comfort, and overall quality of life—and for those who cannot use estrogen-based therapies, options for relief are limited.
To address this need, Katina Robison, MD, Division Chief of Gynecologic Oncology at Tufts Medical Center and Professor of Obstetrics and Gynecology at Tufts University School of Medicine, is leading a new clinical trial at Tufts Medicine. The REVITALIZE study (Alliance A221801) will test whether vaginal fractional CO₂ laser therapy can help reduce dryness and related discomfort for breast cancer survivors. One of the co-Principal Investigators leading the trial nationally is Don S. Dizon, MD, Chief of the Hematology and Oncology Service Line at Tufts Medicine and the Jane F. Desforges Chair in Hematology and Oncology and Professor of Medicine at Tufts University School of Medicine.
"This trial focuses on improving quality of life for women who have already faced so much during their cancer journey. We want to give patients safe, evidence-based options for managing symptoms that can persist long after treatment ends."
Don S. Dizon, MD
The study is sponsored by the Alliance for Clinical Trials in Oncology and is led by Maryam Lustberg, MD, MPH, Professor of Medical Oncology at Yale University Comprehensive Cancer Center, with co-Principal Investigator Allison Quick, MD, Associate Professor of Radiation Oncology at The Ohio State University Comprehensive Cancer Center. By combining expertise across institutions, the trial aims to generate high-quality evidence that can guide care for breast cancer survivors nationwide.
Vaginal fractional CO₂ laser therapy is a minimally invasive procedure lasting about 15 minutes. A small probe delivers tiny pulses of light energy to the vaginal tissue, creating micro-injuries that stimulate blood flow and new collagen production. Over a series of sessions, this process can increase tissue elasticity, moisture and resilience.
REVITALIZE plans to enroll roughly 250 women who experience moderate to severe vaginal dryness after breast cancer treatment. Participants will be randomly assigned to receive either the laser therapy or a placebo procedure, with treatments spaced six weeks apart for a total of three sessions. Patients will be followed for up to two years to assess both short- and long-term outcomes. Those initially assigned to the placebo group can opt to receive the active laser therapy after completing the study.
The primary goal of the trial is to measure improvement in vaginal dryness using an 11-point patient-reported scale. Secondary goals include evaluating discomfort during sexual activity, overall quality of life and any treatment-related side effects.
"Supportive care research like this is essential because many survivors are living decades beyond their initial cancer diagnosis," Dr. Dizon said. "Our hope is that REVITALIZE will provide clear, evidence-based guidance for women and their clinicians, helping to improve comfort and quality of life for survivors everywhere."
