Actively Recruiting
Testing Laser Therapy for Treatment of Vaginal Dryness in Survivors of Breast Cancer, The Revitalize Trial
Led by Alliance for Clinical Trials in Oncology · Updated on 2026-05-11
250
Participants Needed
2
Research Sites
53 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
This phase III trial tests whether vaginal fractional CO2 laser therapy works in treating vaginal dryness in breast cancer survivors. Vaginal dryness can be commonly experienced with normal aging, with menopause, or come about from medications used to treat breast cancer such as chemotherapy or endocrine therapies like tamoxifen or aromatase inhibitors. Vaginal fractional CO2 laser therapy may help reduce vaginal dryness.
CONDITIONS
Official 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 ago
- May be receiving ongoing adjuvant endocrine therapy and must plan to continue it during the 4-month study treatment
- Patient-reported vaginal dryness of moderate or greater severity (score ≥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 with mesh
- No history of certain connective tissue or autoimmune diseases including scleroderma, lupus, and others
- No pelvic surgery involving a vaginal incision within 6 months prior to registration
- No systemic or vaginal estrogen, prasterone, ospemifene, or androgen therapy within 6 weeks prior to registration
- No prior vaginal laser therapy
- No known concurrent invasive cancer; carcinoma in situ is allowed
- Postmenopausal by specified criteria including age, ovarian suppression, bilateral oophorectomy, or AI therapy
- Able to speak, read, and understand English or Spanish
- Age 22 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- No medical history of keloid formation, genital fistula, or thin recto-vaginal septum
You will not qualify if you...
- Evidence of metastatic breast cancer
- Prior gynecologic cancer, pelvic radiation, or pelvic reconstructive surgery involving mesh
- History of 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 before registration
- Use of systemic estrogen, progesterone, vaginal estrogen, vaginal prasterone, ospemifene, or androgen therapy within 6 weeks before registration
- Prior vaginal laser therapy
- Known concurrent invasive carcinoma or malignancy (except carcinoma in situ)
- Medical history of keloid formation, genital fistula, or thin recto-vaginal septum (less than 2 cm between vaginal opening and anal opening)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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