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

Breast Cancer Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04606550
• Other study ID #: 20-0140-A
• Status: Withdrawn
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: October 2022
• Source: Mount Sinai Hospital, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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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Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms
• Genitourinary Syndrome of Menopause

Intervention

Device:
• Microablative Fractional CO2 Laser Therapy
Microablative Fractional CO2 Vaginal Laser Therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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