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

NCT04606550 | Withdrawn

• 1 other identifier: 20-0140-A
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Breast Cancer Female; Genitourinary Syndrome of Menopause

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Vaginal Laser HR+

EXPERIMENTAL

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

Vaginal Estrogen HR-

ACTIVE COMPARATOR

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

Vaginal Laser HR-

ACTIVE COMPARATOR

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

Interventions

Microablative Fractional CO2 Laser Therapy DEVICE

Microablative Fractional CO2 Vaginal Laser Therapy

Also known as: MonaLisa Laser

Vaginal Estrogen HR-; Vaginal Laser HR+; Vaginal Laser HR-

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 28, 2020
• Study Start: September 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: July 1, 2022
• Last Updated: October 13, 2022

Record last verified: 2022-10