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

NCT ID: NCT04517370

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2023-12-30

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.

Conditions

Breast Cancer; Genitourinary Syndrome of Menopause

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Laser treatment

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.

Group Type: ACTIVE_COMPARATOR

Fractional/Pixel CO2 laser

Intervention Type: 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).

Sham treatment

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 .

Group Type: SHAM_COMPARATOR

Fractional/Pixel CO2 laser

Intervention Type: 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).

Interventions

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).

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ahinoam Lev-Sagie, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

Ahinoam Lev-Sagie

Lapid, , Israel

Countries

Israel

Other Identifiers

0392-18-HMO

Identifier Type: -

Identifier Source: org_study_id