CO2 Laser Therapy for the Treatment of GSM in Patients With Breast Cancer
Breast Cancer, Genitourinary Syndrome of Menopause
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
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
Sites / Locations
- Ahinoam Lev-Sagie
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
Laser treatment
Sham 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.
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 .