Actively Recruiting
The Revitalize Trial: Reducing Vaginal Atrophy With Fractional CO2 Laser Therapy for Breast Cancer Survivors
Led by Alliance for Clinical Trials in Oncology · Updated on 2026-05-11
250
Participants Needed
2
Research Sites
34 weeks
Total Duration
On this page
Sponsors
A
Alliance for Clinical Trials in Oncology
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating vaginal fractional CO2 laser therapy for treating vaginal dryness in breast cancer survivors. This phase III trial aims to see if this laser treatment is better than a placebo in reducing vaginal dryness severity, vaginal discomfort during sexual activity, and improving quality of life. The study will also monitor any side effects related to the laser therapy. The trial is sponsored by the Alliance for Clinical Trials in Oncology and involves women who have completed breast cancer treatment. Participants are randomly assigned in a 2:1 ratio to receive either the vaginal fractional CO2 laser therapy or a placebo procedure. Both treatments last 20 to 30 minutes and are given every 6 weeks for a total of three treatments, provided there is no disease progression or unacceptable side effects. After the treatment phase, patients are followed up at 6 weeks, and then at 3, 6, 12, 18, and 24 months to monitor outcomes and safety. During the study, participants will report on their vaginal dryness severity using a numerical scale and answer questionnaires about vaginal discomfort during sex and quality of life. Researchers will also track any adverse events from the treatments for up to 24 months after the last procedure. Participants must be able to read and understand English or Spanish to complete the required questionnaires. The total participation spans from initial treatment through two years of follow-up monitoring.
CONDITIONS
Brief Title
Testing Laser Therapy for Treatment of Vaginal Dryness in Survivors of Breast Cancer, The Revitalize Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with a history of breast cancer treated with curative intent who completed primary therapy at least 12 months before registration
- May be receiving ongoing adjuvant endocrine therapy, with stable treatment for at least 6 months prior to registration
- Patient-reported vaginal dryness of moderate severity or higher (≥4 on a 0-10 scale) lasting at least 3 months
- No evidence of metastatic breast cancer
- No prior gynecologic cancer, vaginal intra-epithelial neoplasia, pelvic radiation, or pelvic reconstructive surgery using mesh
- No history of certain autoimmune or connective tissue diseases including scleroderma, lupus, and dermatomyositis
- No pelvic surgery involving a vaginal incision within 6 months before registration
- No hormone therapies such as systemic or vaginal estrogen or androgen therapies within 6 weeks prior to registration
- No prior vaginal laser therapy
- No known invasive carcinoma or malignancy except carcinoma in situ
- Postmenopausal status by age, ovarian suppression, bilateral oophorectomy, or aromatase inhibitor therapy
- Able to speak, read, and understand English or Spanish
- Age 22 years or older
- ECOG performance status 0 or 1
- No history of keloid formation, genital fistula, or thin recto-vaginal septum (<2 cm)
You will not qualify if you...
- Women who have not completed primary breast cancer therapy at least 12 months before registration
- Evidence of metastatic breast cancer
- Prior vaginal laser therapy at any time
- History of gynecologic cancer, pelvic radiation, or pelvic reconstructive surgery with mesh
- History of autoimmune or connective tissue diseases including scleroderma, lupus, systemic sclerosis, mixed connective tissue disorder, undifferentiated connective tissue disorder, collagen vascular disease, dermatomyositis, polymyositis, lichen sclerosis, or vulvar vestibulitis
- Pelvic surgery involving vaginal incision within 6 months prior to registration
- Use of systemic or vaginal estrogen, vaginal prasterone, ospemifene, or androgen therapy within 6 weeks before registration
- Known concurrent invasive carcinoma or malignancy (except carcinoma in situ)
- History of keloid formation, genital fistula, or thin recto-vaginal septum (<2 cm)
- Inability to speak, read, or understand English or Spanish
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 weeks
Participants undergo vaginal fractional CO2 laser therapy or a placebo procedure every 6 weeks for 3 treatments, each lasting 20 to 30 minutes, in the absence of disease progression or unacceptable toxicity.
3 visits (in-person) every 6 weeks
Duration - Up to 24 months after the last procedure
Participants are followed up to monitor changes in vaginal dryness, vaginal discomfort during sexual activity, quality of life, and any adverse events after completion of study treatments.
6 visits (in-person) over 24 months
Trial Site Locations
Total: 2 locations
1
Trinity Health IHA - Obstetrics and Gynecology West Arbor
Ann Arbor, Michigan, United States, 48103
Actively Recruiting
2
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
M
Maryam Lustberg, MD, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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