Randomized Clinical Trial Comparing the MonaLisa Laser Versus Vaginal Estrogen in Post-Menopausal Breast Cancer Patients: a SHE CAN Non-inferiority Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- MonaLisa Touch Impact on vaginal health in breast caner patients
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
MonaLisa Touch Impact on vaginal health in breast caner patients
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Christine Brezden-Masley
Principal Investigator
Mount Sinai Hospital, Canada