REVITALIZE Trial: Laser Therapy for Breast Cancer Treatment Side Effects

For many breast cancer survivors, completing treatment is often followed by a silent, painful struggle. Treatments ranging from chemotherapy and surgery to long-term endocrine therapies like aromatase inhibitors can trigger genitourinary syndrome of menopause (GSM). This condition, characterized by severe vaginal dryness, irritation and urinary discomfort, can significantly diminish a survivor's quality of life.

In a recent interview with CURE, Dr. Maryam Lustberg, Professor of Medical Oncology at Yale University Comprehensive Cancer Center and study chair for the REVITALIZE trial, sheds light on why this issue is a critical "unmet supportive care need."

“In our patients with breast cancer, [GSM] can be further exacerbated by the treatments that we give them,” Lustberg explained. She noted that while menopause occurs naturally with age, cancer interventions can force younger patients into menopause prematurely. Furthermore, estrogen-blocking therapies essential for preventing cancer recurrence can leave vaginal and urinary tissues dry and friable, leading to pain, bleeding and frequent infections.

To address this, the Alliance for Clinical Trials in Oncology has launched the REVITALIZE study (Alliance A221801). This NCI-sponsored, randomized, placebo-controlled trial is currently enrolling approximately 250 women to test the efficacy of fractional CO₂ laser therapy.

The procedure is minimally invasive, lasting about 15 minutes. During treatment, a small probe delivers pulses of light energy to the vaginal tissue, creating "micro-injuries" that stimulate blood flow and collagen production. The goal is to restore tissue elasticity and moisture without the use of hormones, a vital distinction for survivors whose cancers were hormonally driven and who must avoid estrogen-based treatments.

Participants in the trial are randomized to receive either the laser therapy or a placebo procedure across three sessions, with a 24-month follow-up period to assess long-term relief. "By using a randomized, placebo-controlled design and patient-reported outcomes, REVITALIZE aims to provide clear evidence to guide patients and clinicians," Lustberg said.

As cancer treatments improve and survivors live longer, the focus on survivorship care is intensifying. The findings from REVITALIZE could eventually influence national clinical guidelines, offering a non-hormonal path toward physical comfort and improved intimacy for thousands of women.

Transcript:

What are you and your colleagues hoping to learn through these findings?

REVITALIZE is an NCI-sponsored randomized trial, and this is a this is a part of a National Cooperative Group effort to test an intervention for patients with history of breast cancer who are experiencing symptomatic vaginal dryness or urinary irritation. This syndrome is collectively known in the medical literature as genitourinary syndrome of menopause, and it can happen naturally as a consequence of growing older and menopause, but in our patients with breast cancer, it can be further exacerbated by the treatments that we give them.

For example, our younger patients may entry into menopause, a lot younger than they would have otherwise. So, as a consequence of chemotherapy or surgery, some patients need to have a their ovaries suppressed or have a hysterectomy for cancer risk reduction. So, these younger patients may may experience genitourinary syndrome of menopause that may be even more severe than they would have otherwise experienced.

Additionally, our estrogen-blocking therapies such as aromatase inhibitors and even tamoxifen that we commonly use for hormonally driven breast cancers can actually cause the vaginal and urinary tract tissue areas to become very dry and friable, and this can lead to a multitude of symptoms, including pain, irritation, bleeding or frequent urinary tract infections. And so this is, this is an area of high need.

Transcript has been edited for clarity and conciseness.

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