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.
Additional locations may be listed on ClinicalTrials.gov for NCT05379153.
See trial information on ClinicalTrials.gov for a list of participating sites.
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.
EXPLORATORY OBJECTIVES:
I. To determine whether vaginal fractional CO2 laser treatment is superior to vaginal placebo procedure in reducing the severity of other patient-reported symptoms of the genitourinary syndrome of menopause (GSM) besides vaginal dryness based on an 11-point numerical analog scale.
II. To determine whether vaginal fractional CO2 laser treatment is superior to vaginal placebo procedure in improving other domains of sexual function besides vaginal discomfort during sexual activity based on the PROMIS Sexual Function v 2.0 Brief Profile- Female.
III. To evaluate satisfaction with vaginal fractional CO2 laser therapy.
IV. To describe long-term effects of vaginal fractional CO2 laser therapy.
V. To describe adjuvant endocrine therapy persistence with vaginal fractional CO2 laser treatment compared to placebo procedure in patients with hormone receptor positive (HR+) breast cancer who were taking adjuvant endocrine therapy at registration who are < 5 years out from initiation of endocrine therapy.
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OUTLINE: Patients are randomized to 1 of 2 arms.
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.
Patients will also be asked to complete questionnaires before they start treatment, at every visit and one week after each of their visits.
After completion of study treatment, patients are followed up at 6 weeks, and 3, 6, 12, 18 and 24 months. At the 6 weeks follow-up visit, patients on Arm II may elect to cross-over to Arm I to receive laser treatment.
Trial PhasePhase III
Trial Typesupportive care
Lead OrganizationAlliance for Clinical Trials in Oncology
Principal InvestigatorMaryam Beheshti Lustberg
