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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Genitourinary Syndrome of Menopause Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ahinoam Lev-Sagie

Lapid, 73133, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fractional/Pixel CO2 laser

Device

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).

Primary outcomes

Change in dryness

Time frame: 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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2023
Study completion: 2023
First posted: Aug 18, 2020
Registry last updated: Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed