The Tolerability of Mepitel Film for the Prevention of Radiation Dermatitis in Breast Cancer Patients in Hot Weather: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Frequency of total replacement of Mepitel Film or "touch-up" when compared with the data from the RCT in Ontario, Canada
研究概览
简要总结
Primary Objective To examine the tolerability of Mepitel Film in the prevention of RD patients undergoing whole breast or chest wall RT in the hot and humid weather in Singapore
Secondary Objectives To evaluate the incidence of acute radiation dermatitis, quality of life, satisfaction, and cost analysis of Mepitel Film use.
详细描述
This prospective, observational feasibility study will enroll 60 breast cancer patients, divided into two cohorts: 30 receiving local breast RT and 30 receiving chest wall RT post-mastectomy. We hypothesize that Mepitel Film will be well-tolerated and effective in preventing severe RD (Grade ≥2) in this population, with results compared to published data from Western countries. Previous randomized controlled trials (RCTs) conducted in regions with low humidity and cool temperatures have raised concerns about film adherence and cost in tropical climates. Therefore, assessing the efficacy of Mepitel Film in a hot and humid environment is warranted.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 21 years old (legal age of maturity in Singapore)
- •Male or female
- •Informed consent
- •Patients have undergone a mastectomy with or without reconstruction or breast-conserving surgery.
- •Histological confirmation of breast carcinoma (invasive or in situ carcinoma)
- •Patients are scheduled to receive hypofractionated (40Gy in 15 daily fractions or 26Gy in 5 daily fractions) photon-based RT
- •Patient treated with or without tissue the addition of equivalent bolus and/or boost.
- •Can communicate in English or be aided by a translator.
排除标准
- •Prior RT to any portion of the planned treatment site.
- •Patients will receive partial breast external beam RT, proton beam therapy, or brachytherapy.
- •Patients with active rash, pre-existing dermatitis, or other conditions within the treatment area may make skin assessment for the study difficult per treating physician discretion.
- •Known history of adhesive, tape or silicon allergy or sensitivity.
- •Concomitant cytotoxic chemotherapy
- •Bilateral breast pathology requiring concurrent bilateral breast or chest wall RT.
- •Current inflammatory breast cancer or gross dermal involvement at initiation of RT.
- •Patient has a Karnofsky Performance Status score <60.
结局指标
主要结局
Frequency of total replacement of Mepitel Film or "touch-up" when compared with the data from the RCT in Ontario, Canada
时间窗: From first day RT to the 2 weeks post RT
次要结局
- Radiation-Induced Skin Reaction Assessment Scale (RISRAS) assessed by patient and HCP(From enrollment to 3 months post RT)
- Blinded HCP-assessed mRISRAS scores from blinded grading of photographs taken at the end of RT(End of RT treatment)
- Photographs with EORTC-BCRS(From enrollment to the end of study (2 years post RT))
- Frequency and severity of patient reported pruritis in SSA and RISRAS related to use of Mepitel Film when compared with the data from the RCT in Ontario, Canada(From enrollment to the 3 months post RT)
- Incidence of ARD grades 2 to 3, as defined by the CTCAE V5 assessed by HCP(From enrollment to the 2 weeks post RT)
- Patient-reported skin-related symptoms using the Skin Symptom Assessment (SSA)(From enrollment to the end of study (2 years post RT))
- HCP reported SSA(From enrollment to the end of study (2 years post RT))
- Incidence of moist desquamation assessed by HCP(From enrollment to 2 weeks post RT)
- Patient-reported QOL using the Skindex-16(From enrollment to the end of study (2 years post RT))
- Patient satisfaction with Mepitel Film as assessed by the patient satisfaction questionnaire(3 months post RT)
- HCP satisfaction with Mepitel Film as assessed by the HCP satisfaction questionnaire(3 months post RT)
- Cost analysis of Mepitel Film for prevention of RD (evaluation and calculation of Mepitel Film usage and financial cost using Film Integrity Assessment)(From first day RT to the 2 weeks post RT)