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.
Testing Laser Therapy for Treatment of Vaginal Dryness in Survivors of Breast Cancer, The Revitalize Trial
The Revitalize Trial: Reducing Vaginal Atrophy With Fractional CO2 Laser for Breast Cancer Survivors
Breast cancer
Female
22+
Recruiting now
Overview
Principal Investigator: Katina Robinson, MD
Contact Us
Latoya Marshall
Study details
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.gibility.
- 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
Exclusion Criteria
- Prior gynecologic cancer, vaginal intra-epithelial neoplasia, pelvic radiation or pelvic reconstructive surgery utilizing mesh.
- 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.
- Other suspected contraindications for undergoing laser therapy.
Study Requirements
Experimental: Arm I (vaginal fractional CO2 laser therapy)
Patients undergo vaginal fractional CO2 laser therapy over 20-30 minutes every 6 weeks for 3 treatments in the absence of disease progression or unacceptable toxicity.
Interventions:
Device: Laser Therapy
Other: Questionnaire Administration
Other: Quality of Life Assessment
Sham Comparator: Arm II (placebo)
Patients undergo placebo procedure over 20-30 minutes every 6 weeks for 3 treatments in the absence of disease progression or unacceptable toxicity.
Interventions:
Device: Sham Intervention
Other: Questionnaire Administration
Other: Quality of Life Assessment