The Revitalize Trial: Reducing Vaginal Atrophy With Fractional CO2 Laser for Breast Cancer Survivors
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.
Detailed 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.) 2.0 Brief Profile-Female. II. To determine whether vaginal fractional CO2 laser therapy results in improvement in patient-reported quality of life, based on a single item 11-point numerical analog scale. III. To evaluate potential toxicities associated with vaginal fractional CO2 laser therapy. OUTLINE: Patients are randomized at a 2:1 ratio to Arm I and Arm II. ARM I: 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. ARM II: Patients undergo placebo procedure over 20-30 minutes every 6 weeks for 3 treatments in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 6 weeks, and 3,6, 12, 18 and 24 months after the last procedure visit.
Arms & interventions
- DeviceLaser Therapy
Undergo vaginal fractional CO2 laser therapy
- DeviceSham Intervention
Undergo placebo procedure
- OtherQuestionnaire Administration
Ancillary studies
- OtherQuality of Life Assessment
Ancillary studies
Outcome measures
Primary
Changes in patient reported vaginal dryness severity
Will use an 11-point (0-10) numerical analog scale to assess patient reported severity of vaginal dryness. Higher scores represent worse symptoms (0: None - 10: Worst possible). The vaginal dryness scores at each time point will be summarized separately by treatment arm using the mean (standard deviation) and median (range). The score changes from baseline to the 18-week time point (T4) will be compared using two-sample t-test or Wilcoxon rank-sum test as appropriate.
Time frame: Up to 18 weeks
Secondary
Changes in vaginal discomfort during sexual activity (for sexually active subset of study population only)
Time frame: Baseline up to 24 months after completion of treatment
Change in quality of life
Time frame: Baseline up to 24 months after completion of treatment
Incidence of adverse events associated with vaginal fractional CO2 laser therapy
Time frame: Up to 24 months after completion of treatment
Eligibility criteria
Study locations (2)
Trinity Health IHA - Obstetrics and Gynecology West Arbor
Ann Arbor, Michigan, 48103
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210