Breast Cancer FemaleNCT04606550
MonaLisa Laser Intervention for Post-Menopausal Breast Cancer Patients: A SHE CAN Study
A study testing Microablative Fractional CO2 Laser Therapy in people with Breast Cancer Female and Genitourinary Syndrome of Menopause, run by Mount Sinai Hospital, Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer Female, Genitourinary Syndrome of Menopause
- What is being tested?
- Microablative Fractional CO2 Laser Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
- -
About this 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
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.
Read the 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.
- Being tested
- Microablative Fractional CO2 Laser Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microablative Fractional CO2 Laser TherapyDevice
Also called MonaLisa Laser
Microablative Fractional CO2 Vaginal Laser Therapy
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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). Receives: Device: Microablative Fractional CO2 Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start1 Sep 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Jul 2022 (estimated)
Why it stopped: No financial support.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Brezden-Masley, Mount Sinai Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606550
- Sponsor's protocol ID
- 20-0140-A
- Status last verified
- Oct 2022
- First submitted
- 9 Oct 2020
- Last updated
- 13 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Comparing the MonaLisa Laser Versus Vaginal Estrogen in Post-Menopausal Breast Cancer Patients: a SHE CAN Non-inferiority Study
- ClinicalTrials.gov ID
- NCT04606550
- Acronym / sponsor ID
- 20-0140-A
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No financial support.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 28 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vaginal Laser HR+ | Experimental | Device: Microablative Fractional CO2 Laser TherapyDuring 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). |
| Vaginal Estrogen HR- | Active comparator | Device: Microablative Fractional CO2 Laser TherapyThe 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. |
| Vaginal Laser HR- | Active comparator | Device: Microablative Fractional CO2 Laser TherapyDuring 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microablative Fractional CO2 Laser TherapyAlso: MonaLisa LaserMicroablative Fractional CO2 Vaginal Laser Therapy | Device | Vaginal Estrogen HR-, Vaginal Laser HR+, Vaginal Laser HR- |
Primary outcome
MonaLisa Touch Impact on vaginal health in breast caner patients
Time frame: 2 years
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
Time frame: 6 months
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Microablative Fractional CO2 Laser Therapy in people with Breast Cancer Female and Genitourinary Syndrome of Menopause, run by Mount Sinai Hospital, Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MonaLisa Touch Impact on vaginal health in breast caner patients (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.