Spots Global Cancer Trial Database for Laser Therapy for Vulvovaginal Symptoms in Breast Cancer Patients

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Trial Identification

Brief Title: Laser Therapy for Vulvovaginal Symptoms in Breast Cancer Patients

Official Title: Laser Therapy for Vulvovaginal Symptoms in Breast Cancer Patients

Study ID: NCT03628092

Conditions

Vulvovaginal Atrophy

Genitourinary Symptoms and Ill-Defined Conditions

Interventions

CO2 Fractional Ablative Laser

Placebo

Study Description

Brief Summary: To determine the efficacy of ablative carbon dioxide laser in the treatment of the signs and symptoms of vulvovaginal atrophy (VVA) or genitourinary syndrome of menopause (GSM) in women with breast cancer.

Detailed Description: LAAVA 2 is a double blinded randomised placebo/sham-controlled trial assessing whether fractional ablative carbon dioxide is beneficial in improving symptoms in women with a history of early breast cancer. Patients will be randomly assigned in a 1:1 ratio to either active laser treatment or inactive "sham" laser treatment (setting of close to zero) Participants will receive the 3 treatments approximately 4 weeks apart. Participants will then be followed up at twelve weeks post completion of treatment and twelve months post completion of treatment. At the twelve week follow up visit, after completion of study procedures, patients will be unblinded and those who received "sham" treatment will be allowed to crossover to "active" treatment if they wish.