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

Not Applicable

Completed

• Conditions: Breast Cancer; Genitourinary Syndrome of Menopause

• Registration Number: NCT04517370
• Lead Sponsor: Hadassah Medical Organization

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2020-08-16
• Study First Submitted QC: 2020-08-16
• Study First Posted: 2020-08-18
• Status Verified: 2023-03
• Primary Completion: 2023-06-30
• Study Completion: 2023-12-30
• Last Update Submitted: 2024-03-10
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Change in dryness	Follow up after 3 treatments and at 1 month, 3 months and 6 months after last treatment.	Change in VAS before and after completion of treatment for dryness
Change in dyspareunia	Follow up after 3 treatments and at 1 month, 3 months and 6 months after last treatment.	Change in VAS before and after completion of treatment for dyspareunia

Trial Locations

Locations (1)

Ahinoam Lev-Sagie; 🇮🇱 Lapid, Israel