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CO2 Laser Therapy for the Treatment of GSM in Patients With Breast Cancer | Clinical Trials | Clareo Health

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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

NCT04517370•Hadassah Medical Organization

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Patients diagnosed with breast cancer
•2. Menopause: spontaneous, surgical or chemotherapy induced
•3. One or more GSM Symptoms: dryness, irritation, burning, pain, dyspareunia, dysuria
•4. On exam, clinical findings of atrophy: thin, dry, pale vagina
•5. Age\>18
•6. Normal Pap smear within 3 years

Exclusion Criteria

•1. Menstruation
•2. Chemotherapy
•3. Vaginal bleeding which did not underwent evaluation
•4. Concurrent treatment with topical estrogen
•5. Previous vulvar, vaginal or cervical dysplasia\\ cancer

Locations (1)

Ahinoam Lev-Sagie

Lapid, Israel

Key Dates

Start Date

February 1, 2019

Primary Completion Date

June 30, 2023

Completion Date

December 30, 2023

Last Updated

March 12, 2024

Enrollment

ACTUAL participants

Conditions

Breast CancerGenitourinary Syndrome of Menopause

Interventions

Fractional/Pixel CO2 laser

DEVICE

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer