Breast Cancer, Genitourinary Syndrome of Menopause
Conditions
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.
Interventions
DEVICEFractional/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).
Sponsors
Hadassah Medical Organization
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in dryness | Follow up after 3 treatments and at 1 month, 3 months and 6 months after last treatment. | Change in VAS before and after completion of treatment for dryness |
| Change in dyspareunia | Follow up after 3 treatments and at 1 month, 3 months and 6 months after last treatment. | Change in VAS before and after completion of treatment for dyspareunia |
Countries
Israel
Outcome results
None listed