Testing Laser Therapy for Treatment of Vaginal Dryness in Survivors of Breast Cancer, The Revital… (NCT05379153) | Clinical Trial Compass
RecruitingPhase 3
Testing Laser Therapy for Treatment of Vaginal Dryness in Survivors of Breast Cancer, The Revitalize Trial
United States250 participantsStarted 2026-04-21
Plain-language summary
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.
Who can participate
Age range22 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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. Pat…
What they're measuring
1
Changes in patient reported vaginal dryness severity