Testing Laser Therapy for Treatment of Vaginal Dryness in Survivors of Breast Cancer, The Revitalize Trial
Sponsor: Alliance for Clinical Trials in Oncology • ClinicalTrials.gov ID: NCT05379153
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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.
Interventions
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Laser Therapy
(Device)
Undergo vaginal fractional CO2 laser therapy
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Sham Intervention
(Device)
Undergo placebo procedure
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Questionnaire Administration
(Other)
Ancillary studies
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Quality of Life Assessment
(Other)
Ancillary studies
Eligibility criteria
Conditions
Locations
- Iowa Methodist Medical Center — Des Moines, Iowa, United States
- Trinity Health IHA - Obstetrics and Gynecology West Arbor — Ann Arbor, Michigan, United States
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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