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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04517370
• Other study ID #: 0392-18-HMO
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2023
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Genitourinary Syndrome of Menopause

Intervention

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).

Locations

Country	Name	City	State
Israel	Ahinoam Lev-Sagie	Lapid

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in dryness	Change in VAS before and after completion of treatment for dryness	Follow up after 3 treatments and at 1 month, 3 months and 6 months after last treatment.
Primary	Change in dyspareunia	Change in VAS before and after completion of treatment for dyspareunia	Follow up after 3 treatments and at 1 month, 3 months and 6 months after last treatment.