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

Not Applicable

Completed

• Conditions: Breast Cancer; Genitourinary Syndrome of Menopause
• Interventions: Device: Fractional/Pixel CO2 laser

• 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

Arm && Interventions

Group	Intervention	Description
Laser treatment	Fractional/Pixel CO2 laser	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.
Sham treatment	Fractional/Pixel CO2 laser	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 .

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