NCT04517370

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Hadassah Medical Organization · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Breast Cancer
• Genitourinary Syndrome of Menopause

Interventions

Type	Name	Description
DEVICE	Fractional/Pixel CO2 laser	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).

Timeline

• Start date: 2019-02-01
• Primary completion: 2023-06-30
• Completion: 2023-12-30
• First posted: 2020-08-18
• Last updated: 2024-03-12

Locations

1 site across 1 country: Israel