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

Hadassah Medical Center

Status: Completed

Conditions: Breast Cancer; Genitourinary Syndrome of Menopause

Treatments: Device: Fractional/Pixel CO2 laser

Study type: Interventional

Funder types: Other

Identifiers

NCT04517370

0392-18-HMO

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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36 participants in 2 patient groups

Laser treatment

Active Comparator group

Description:

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.

Treatment:

Device: Fractional/Pixel CO2 laser

Sham treatment

Sham Comparator group

Description:

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 .

Treatment:

Device: Fractional/Pixel CO2 laser