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

Primary Purpose

Breast Cancer Female, Genitourinary Syndrome of Menopause

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Microablative Fractional CO2 Laser Therapy
Sponsored by
Mount Sinai Hospital, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer Female

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    Vaginal Laser HR+

    Vaginal Estrogen HR-

    Vaginal Laser HR-

    Arm Description

    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).

    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.

    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).

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 9, 2020
    Last Updated
    October 11, 2022
    Sponsor
    Mount Sinai Hospital, Canada
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04606550
    Brief Title
    MonaLisa Laser Intervention for Post-Menopausal Breast Cancer Patients: A SHE CAN Study
    Official Title
    Randomized Clinical Trial Comparing the MonaLisa Laser Versus Vaginal Estrogen in Post-Menopausal Breast Cancer Patients: a SHE CAN Non-inferiority Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No financial support.
    Study Start Date
    September 1, 2021 (Anticipated)
    Primary Completion Date
    December 1, 2021 (Anticipated)
    Study Completion Date
    July 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mount Sinai Hospital, Canada

    4. Oversight

    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

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer Female, Genitourinary Syndrome of Menopause

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Vaginal Laser HR+
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Vaginal Estrogen HR-
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Vaginal Laser HR-
    Arm Type
    Active Comparator
    Arm Description
    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).
    Intervention Type
    Device
    Intervention Name(s)
    Microablative Fractional CO2 Laser Therapy
    Other Intervention Name(s)
    MonaLisa Laser
    Intervention Description
    Microablative Fractional CO2 Vaginal Laser Therapy
    Primary Outcome Measure Information:
    Title
    MonaLisa Touch Impact on vaginal health in breast caner patients
    Description
    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.
    Time Frame
    2 years
    Title
    VAS
    Description
    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.
    Time Frame
    6 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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 -

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

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