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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Breast Cancer Female; Genitourinary Syndrome of Menopause
• Intervention / Treatment: Device: Microablative Fractional CO2 Laser Therapy

Detailed Description

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Provide written and voluntary informed consent understood, signed and dated
2. Aged between 18 and 75 years old
3. Have had previous histologically-proven diagnosis of breast cancer
4. Have moderate to severe GSM symptoms as determined by their treating oncologist or another responsible physician.
5. Interested in receiving treatment for their GSM symptoms, and willing to be randomized to a treatment arm in this protocol.
6. 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.
7. For hormone receptor negative cohort, must be post-menopausal
8. ECOG status <2

Exclusion Criteria:

1. Have a suspected or diagnosed gynecological illness or malignancy.
2. Inability to attend outpatient clinics for any reason.
3. Inability to provide consent or complete the questionnaire (e.g. Language barrier, concerns about competence)
4. Contraindication to vaginal estrogen therapy
5. Personal history of thrombophlebitis, heart failure, or myocardial infarction within 12 months, scleroderma, or any chronic condition that could interfere with study compliance.
6. Pelvic organ prolapse higher than stage II, pelvic surgery within 6 months, or previous reconstructive pelvic surgery with transvaginal mesh kits.
7. 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.
8. 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
9. Acute or recurrent urinary tract infection (UTI), or genital infection (e.g. bacterial vaginosis, herpes genitalis, candida, pelvic inflammatory disease)
10. Personal history of impaired wound healing or Scleroderma
11. History of keloid formation

12. Use or anticipated use of antiplatelet therapy, anticoagulants, thrombolytics, vitamin E or nonsteroidal anti-inflammatory drugs within 2 weeks pre-treatment

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vaginal Laser HR+; 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; Microablative Fractional CO2 Vaginal Laser Therapy; Other Names: MonaLisa Laser
Active Comparator: Vaginal Estrogen HR-; 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; Microablative Fractional CO2 Vaginal Laser Therapy; Other Names: MonaLisa Laser
Active Comparator: Vaginal Laser HR-; 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; Microablative Fractional CO2 Vaginal Laser Therapy; Other Names: MonaLisa Laser

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mount Sinai Hospital, Canada

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: October 9, 2020
• First Submitted That Met QC Criteria: October 22, 2020
• First Posted (Actual): October 28, 2020

Study Record Updates

• Last Update Posted (Actual): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 11, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 20-0140-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No