Mepitel Film vs Standard of Care for the Radiotherapy Prevention and Cutaneous Toxicity in Patients With Post-surgery Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 164
- 试验地点
- 2
- 主要终点
- Mepitel Film efficacy in treating skin toxicity evaluatet with Common Terminology Criteria for Adverse Events (CTCAE)
研究概览
简要总结
This is a randomized study, mepitel vs standard of care for the prevention and skin toxicity due to radiotherapy in patients with post-surgery breast cancer.
Mepitel film will be placed on the skin of the patients just before the start of the radiotherapy and will be replaced once a week until the end of the radiotherapy. In case of skin toxicities mepitel film will be placed until resolution of toxicities.
详细描述
For patients randomized in the mepitel arm:
Mepitel film will be placed on the patients' skin just before the start of the radiotherapy and will be replaced once a week until the end of the radiotherapy. In case of skin toxicities mepitel film will be placed until resolution of the toxicities. In case of new skin toxicities appearance the patient will be retreated with mepitel.
For patients randomized in the standard of treatment arm:
Patients will be treated with aqueous (Excipial U hydrolotion) or antiseptic (Flammazine o Ialugen Plus) cream in case of skin erythema. In case of new skin toxicities appearance the patient will be retreated with standard of care treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients with breast cancer treated with conservative surgery who need radiotherapy treatment
- •capability and willness to participate to the study
- •informed consent form signature
排除标准
- •contraindication to the correct placement of the Mepitel Film
- •previous breast radiation treatment
- •participating in other clinical trials
- •previous breast reconstruction
- •concomitant treatment with antiblastic chemotherapy
研究组 & 干预措施
Mepitel Film
Mepitel film will be placed on the patients' skin just before the start of the radiotherapy and will be replaced once a week until the end of the radiotherapy. In case of skin toxicities mepitel film will be placed until resolution of the toxicities. In case of new skin toxicities appearance the patient will be retreated with Mepitel.
干预措施: Mepitel Film (Device)
Excipial U hydrolotion, Flammazin skin cream
Patients will be treated with aqueous (Excipial U hydrolotion) or antiseptic (Flammazine or Ialugen Plus) cream in case of skin erythema due to radiotherapy. In case of new skin toxicities appearance the patient will be retreated with standard of care treatment.
干预措施: skin cream (Drug)
结局指标
主要结局
Mepitel Film efficacy in treating skin toxicity evaluatet with Common Terminology Criteria for Adverse Events (CTCAE)
时间窗: one week after start of radiotherapy
Common Terminology Criteria for Adverse Events (CTCAE) V.4 will be used to evaluate the toxicity
次要结局
- Time for the skin toxicity appearance and resolution(one week after start of radiotherapy)
- Severity of the chronic skin toxicity(one week after start of radiotherapy)
研究者
Dario Valcarenghi
Clinical Research Nurse
Oncology Institute of Southern Switzerland