Clinical trial · Interventional
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
NCT04606550CI-TRIAL-00061449withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No financial support.
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
| Genitourinary Syndrome of Menopause | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Microablative Fractional CO2 Laser Therapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Vaginal Laser HR+
- 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).
- interventionNames
- Device: Microablative Fractional CO2 Laser Therapy
- type
- ACTIVE_COMPARATOR
- label
- Vaginal Estrogen HR-
- 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.
- interventionNames
- Device: Microablative Fractional CO2 Laser Therapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
\-References
Publications (0)
Data not yet available
No reference posted for this study.