Vaginal CO2 laser for vaginal dryness in breast cancer survivors
The Revitalize Trial: Reducing Vaginal Atrophy With Fractional CO2 Laser for Breast Cancer Survivors
This trial will test whether a vaginal fractional CO2 laser can reduce vaginal dryness in women who have finished breast cancer treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 22 Years and up |
| Sex | Female |
| Sponsor | Alliance for Clinical Trials in Oncology Academic / other |
| Drugs / interventions | trastuzumab, pertuzumab, chemotherapy, immunotherapy, radiation |
| Locations | 2 sites (Ann Arbor, Michigan and 1 other locations) |
| Trial ID | NCT05379153 on ClinicalTrials.gov |
What this trial studies
This is a randomized phase III trial that assigns participants 2:1 to receive either vaginal fractional CO2 laser therapy or a sham procedure, given three times about six weeks apart, with follow-up to 24 months. The primary outcome is change in patient-reported vaginal dryness on an 11-point (0-10) numeric scale. Secondary outcomes include patient-reported vaginal discomfort during sex (PROMIS Sexual Function), a single-item quality-of-life numeric scale, and monitoring for procedure-related toxicities. Eligible participants are women treated with curative intent for breast cancer at least 12 months earlier and may be on stable endocrine therapy.
Who should consider this trial
Good fit: Women who completed primary breast cancer treatment at least 12 months ago, are experiencing bothersome vaginal dryness, can attend three in-clinic procedures and follow-up visits, and will remain on a stable endocrine regimen if applicable.
Not a fit: Patients with active recurrent disease, those less than 12 months from primary therapy, or people whose vaginal symptoms are due to non-gynecologic causes may not receive benefit from this intervention.
Why it matters
Potential benefit: If successful, the treatment could offer a non-hormonal option to reduce vaginal dryness and improve sexual comfort and overall quality of life for breast cancer survivors.
How similar studies have performed: Prior small trials and observational studies of vaginal CO2 laser for genitourinary syndrome of menopause and in cancer survivors have reported symptom improvements, but results have been mixed and high-quality randomized evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women with a history of breast cancer treated with curative intent who have completed primary therapy (consisting of surgery with or without chemotherapy, targeted therapy, immunotherapy and/or radiation) \>= 12 months prior to registration. Concurrent trastuzumab /pertuzumab is permissible * May be receiving ongoing adjuvant endocrine therapy (with an AI or tamoxifen +/- ovarian function suppression). Patients are not required to receive these treatments to be eligible. Participants receiving adjuvant endocrine therapy prior to registration must intend to continue the same endocrine therapy for the 4 months while they are receiving protocol treatment, unless a clinically necessary change is indicated at the discretion of the patient's medical oncologist. Patients on aromatase inhibitor (AI) therapy, tamoxifen with or without ovarian function suppression therapy must have been on their current endocrine therapy regimen for at least 6 months prior to registration * Patient-reported vaginal dryness with or without dyspareunia of at least moderate severity on average, defined as \>= 4 on a 0-10-point scale that has been bothersome for \>= 3 months and for which the patient wants to undergo the study procedure * No evidence of metastatic breast cancer. Scans to assess for metastatic disease are not required for eligibility * No prior gynecologic cancer, vaginal intra-epithelial neoplasia, pelvic radiation or pelvic reconstructive surgery utilizing mesh. Patients with cervical intraepithelial neoplasia are eligible * No history of scleroderma, lupus, systemic sclerosis, mixed connective tissue disorder, undifferentiated connective tissue disorder or collagen vascular disease, dermatomyositis, polymyositis, lichen sclerosis or vulvar vestibulitis * No pelvic surgery that involved a vaginal incision within 6 months of registration. Patients who received laparoscopic BSO (Bilateral salpingooophorectomy) are eligible * No systemic estrogen or progesterone, vaginal estrogen, vaginal prasterone, ospemifene, and/or androgen therapy within 6 weeks prior to registration * No other suspected contraindications for undergoing laser therapy * No prior vaginal laser therapy at any time. Patients who would have completed any type of vaginal laser resurfacing procedure at any time prior to the start of study treatment are not eligible * No known concurrent invasive carcinoma/malignancy. Patients with carcinoma in situ are eligible. Patients with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible if not currently receiving treatment * Postmenopausal based on at least one of the following criteria at the time of registration: * Women 50 or older with no spontaneous regular menses \> 12 months * On ovarian suppression (i.e., gonadotrophin releasing hormone \[GNRH\] agonist/antagonist) for at least 6 months or greater, with plans to continue such treatment for at least 18 weeks * Bilateral oophorectomy * Women on AI therapy (i.e., clinically judged to be postmenopausal) * In order to complete the mandatory patient-completed measures, participants must be able to speak, read and understand English or Spanish * Age \>= 22 years * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * No medical history of: keloid formation, genital fistula, thin recto-vaginal septum (defined as a distance of \< 2 cm between the vaginal opening and the anal opening)
Where this trial is running
Ann Arbor, Michigan and 1 other locations
- Trinity Health IHA - Obstetrics and Gynecology West Arbor — Ann Arbor, Michigan, United States (Recruiting)
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Maryam Lustberg, MD, MPH
- Email: Maryam.lustberg@yale.edu
- Phone: (203) 785-4095
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.