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Testing Laser Therapy for Treatment of Vaginal Dryness in Survivors of Breast Cancer, The Revitalize Trial

Major Program
Supportive Care and Symptom Management
NCI Community Oncology Research Program
Research Group
Community Oncology and Prevention Trials
Sponsor
Alliance for Clinical Trials in Oncology
Status
Recruiting
NCT ID
NCT05379153
This phase III trial compares the effect of vaginal fractional CO2 laser therapy to placebo for the treatment of vaginal dryness in breast cancer survivors with symptoms of genitourinary syndrome of menopause (GSM). Placebo therapy is an inactive treatment that is designed to mimic as closely as possible the active treatment being studied in a clinical trial. In this trial, patients will not be told whether they will be in the laser treatment group or the placebo group until 6-weeks after the third treatment visit (patient-blinded). At that point, patients who received placebo can elect to receive laser treatment similar to the other group. GSM is group of symptoms that affect the female genital and urinary systems and results from the lack of estrogen. 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. compared to placebo.
Intervention
Laser Therapy, Quality of Life Assessment, Questionnaire Administration, Sham Intervention
Condition
Vaginal Atrophy, Breast Carcinoma
Investigators
Maryam Lustberg, MD, MPH, Site Public Contact, Gina B. Long
CT Research Area
Symptom Science

See list of participating sites