MonaLisa Laser Intervention for Post-Menopausal Breast Cancer Patients: A SHE CAN Study

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy of a fractional CO2 laser (SmartXide2 - V2LR, DEKA M.E.L.A., Florence - Italy) the Laser in the treatment of genitourinary symptoms of menopause, female sexual function, and urogenital health in comparison to vaginal estrogen. Only breast cancer patients who have HR (-) breast cancer are planning to be included in the vaginal estrogen group.

Detailed Description
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The investigators aim to determine the efficacy of the MonaLisaTouch Laser in comparison with vaginal estrogen in the management and treatment of GSM symptoms resulting in vaginal atrophy, sexual dysfunction and a decreased quality of life in women with a history of breast cancer. Patients will be stratified according to menopausal status prior to breast cancer therapy and HR tumor status. Fractional CO2 laser therapy has been approved by Health Canada for use in menopausal women with GSM, nevertheless long term efficacy and safety data is lacking in the breast cancer survivor population. In the short term (i.e. 6 month follow up), research has shown that this therapy is a safe and effective treatment that has promising benefits with little to no reported adverse events.

Official Title
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Randomized Clinical Trial Comparing the MonaLisa Laser Versus Vaginal Estrogen in Post-Menopausal Breast Cancer Patients: a SHE CAN Non-inferiority Study

Conditions
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Breast Cancer Female, Genitourinary Syndrome of Menopause

Intervention / Treatment
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* Device: Microablative Fractional CO2 Laser Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide written and voluntary informed consent understood, signed and dated Aged between 18 and 75 years old Have had previous histologically-proven diagnosis of breast cancer Have moderate to severe GSM symptoms as determined by their treating oncologist or another responsible physician. Interested in receiving treatment for their GSM symptoms, and willing to be randomized to a treatment arm in this protocol. Completed chemotherapy and / or radiation treatment at least 3 months prior to starting the study, and/or maintenance endocrine therapy for at least 3 months prior to starting the study. For hormone receptor negative cohort, must be post-menopausal ECOG status <2 Exclusion Criteria: Have a suspected or diagnosed gynecological illness or malignancy. Inability to attend outpatient clinics for any reason. Inability to provide consent or complete the questionnaire (e.g. Language barrier, concerns about competence) Contraindication to vaginal estrogen therapy Personal history of thrombophlebitis, heart failure, or myocardial infarction within 12 months, scleroderma, or any chronic condition that could interfere with study compliance. Pelvic organ prolapse higher than stage II, pelvic surgery within 6 months, or previous reconstructive pelvic surgery with transvaginal mesh kits. Have used vaginal estrogen cream, ring or tablet within 1month before entering the study, or vaginal moisturizers, lubricants or homeopathic preparations within 2 weeks of therapy. Personal history of vulvovaginal condyloma, vaginal intraepithelial neoplasia (VAIN), vaginal carcinoma, lichen sclerosis, lichen planus, history of vaginal radiation, history of cervical cancer, other gynaecologic cancer, pelvic or vaginal radiation Acute or recurrent urinary tract infection (UTI), or genital infection (e.g. bacterial vaginosis, herpes genitalis, candida, pelvic inflammatory disease) Personal history of impaired wound healing or Scleroderma History of keloid formation Use or anticipated use of antiplatelet therapy, anticoagulants, thrombolytics, vitamin E or nonsteroidal anti-inflammatory drugs within 2 weeks pre-treatment -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaginal Laser HR+<br>During our study, women will undergo treatment intravaginally and vulvar with the fractional microablative CO2 laser system (SmartXide 2 V 2 LR, MonaLisa Touch, DEKA, Florence, Italy). A treatment cycle includes three laser applications (every 40-50 days, approximately 6 weeks). The procedure will be performed in the outpatient clinic and does not require any specific preparation (e.g. analgesia/anesthesia). | Device: Microablative Fractional CO2 Laser Therapy<br>* Microablative Fractional CO2 Vaginal Laser Therapy<br>* Other names: MonaLisa Laser;|
| Active Comparator: Vaginal Estrogen HR-<br>The women in the vaginal estrogen group will be prescribed and asked to administer: Conjugated estrogen cream (Premarin®): 0.5 g of cream intravaginally daily (using applicator or fingertip) for two weeks (fourteen days) then 0.5 g twice weekly for 24 ± 2 additional weeks. | Device: Microablative Fractional CO2 Laser Therapy<br>* Microablative Fractional CO2 Vaginal Laser Therapy<br>* Other names: MonaLisa Laser;|
| Active Comparator: Vaginal Laser HR-<br>During our study, women will undergo treatment intravaginally and vulvar with the fractional microablative CO2 laser system (SmartXide 2 V 2 LR, MonaLisa Touch, DEKA, Florence, Italy). A treatment cycle includes three laser applications (every 40-50 days, approximately 6 weeks). The procedure will be performed in the outpatient clinic and does not require any specific preparation (e.g. analgesia/anesthesia). | Device: Microablative Fractional CO2 Laser Therapy<br>* Microablative Fractional CO2 Vaginal Laser Therapy<br>* Other names: MonaLisa Laser;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MonaLisa Touch Impact on vaginal health in breast caner patients | The aim of our research, is to assess the impact of the MonaLisa Touch Laser on the sexual health and quality of life of breast cancer survivors with GSM in comparison to vaginal estrogen. | 2 years | 
| VAS | To compare subjective improvement of vaginal dryness in breast cancer survivors, using the 10 cm visual analog scale (VAS) for GSM symptoms 6 months post-treatment between groups. | 6 months |