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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer, Genitourinary Syndrome of Menopause

Intervention / Treatment
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* Device: Fractional/Pixel CO2 laser


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laser treatment<br>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. | Device: Fractional/Pixel CO2 laser<br>* 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).<br>|
| Sham Comparator: Sham treatment<br>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 . | Device: Fractional/Pixel CO2 laser<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. |