CO2 Laser Therapy for the Treatment of GSM in Patients With Breast Cancer

CO2 Laser Therapy for the Treatment of GSM in Patients With Breast Cancer A Comparative, Randomized, Controlled Trial

Given the need for an effective, non-hormonal treatment for Genitourinary syndrome of menopause GSM) symptoms in breast cancer survivors, the reported efficacy of fractional CO2 laser as such a treatment in retrospective studies, the study aims to evaluate the efficacy of CO2 laser for the treatment of GSM in breast cancer patients, in a prospective, randomized, blinded, placebo-controlled trial.

Each patient will be treated once every 20-40 days, for a total of 3 laser treatments. In every visit during the study, patients will undergo gynecological examination and will complete questionnaires evaluating GSM symptoms, using a visual analogue scale (VAS) for each symptom (vaginal dryness, dyspareunia, discharge, itching and/or stinging, vaginal bleeding and dysuria) as well as treatment induced pain and side effects.

Each patient will be treated once every 20-40 days, for a total of 3 Sham treatments, in a similar procedure not using an active laser energy. Patients will be assessed in a similar manner. Following 3 Sham-treatments patients in the placebo group will be offered the laser treatment in an open-label study .

The treatment is done with a specialized vaginal applicator which allows treatment of vagina, using the Femilift fractional micro ablative CO2 laser system (Alma Lasers, Israel), according to the usual protocol (Laser mode: Pulse, Energy: 40-80 mj/pulse). Before treatment, 5ml of topical anesthetic ointment (10% lidocaine in Vaseline base) will be spread in the vagina and on the vestibule for 30 minutes in both groups to avoid pain from the laser, as well as to allow the comparison between the groups (patients in both groups will not experience pain and therefore will remain blinded to their allocation).

Inclusion criteria: Patients diagnosed with breast cancer Menopause: spontaneous, surgical or chemotherapy induced One or more GSM Symptoms: dryness, irritation, burning, pain, dyspareunia, dysuria On exam, clinical findings of atrophy: thin, dry, pale vagina Age>18 Normal Pap smear within 3 years Exclusion criteria: Menstruation Chemotherapy Vaginal bleeding which did not underwent evaluation Concurrent treatment with topical estrogen Previous vulvar, vaginal or cervical dysplasia\ cancer