The Revitalize Trial: Reducing Vaginal Atrophy With Fractional CO2 Laser for Breast Cancer Survivors
Alliance for Clinical Trials in Oncology
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.
Description
PRIMARY OBJECTIVE: I. To determine whether vaginal fractional carbon dioxide (CO2) laser treatment is superior to vaginal placebo procedure in improving the severity of vaginal dryness, based on an 11-point (0-10) patient reported numerical analog scale. SECONDARY OBJECTIVES: I. To determine whether vaginal fractional CO2 laser treatment is superior to vaginal placebo procedure in improving patient-reported vaginal discomfort during sexual activity, based on the vaginal discomfort domain of the Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function version (v.) 2.…
Eligibility
- Age range
- 22+ years
- Sex
- Female
- Healthy volunteers
- No
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 s…
Interventions
- DeviceLaser Therapy
Undergo vaginal fractional CO2 laser therapy
- DeviceSham Intervention
Undergo placebo procedure
- OtherQuestionnaire Administration
Ancillary studies
- OtherQuality of Life Assessment
Ancillary studies
Location
- Trinity Health IHA - Obstetrics and Gynecology West ArborAnn Arbor, Michigan