Novel ROS-scavenging Nanoenzymes for the Treatment of Radiation Dermatitis in Patients With Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The incidence of grade 2 or higher radiation dermatitis
研究概览
简要总结
There is no standard treatment for radiation dermatitis. In this study, the investigators have designed novel ROS-scavenging nanoenzymes and aim to evaluate their effectiveness in preventing radiation dermatitis in patients with head and neck cancer.
详细描述
Radiotherapy often leads to various complications, with radiation dermatitis being the most common side effect observed in the majority of tumor patients undergoing treatment. This condition not only affects a patient's appearance but, in severe cases, may even require the interruption of treatment.
Currently, there is no standard treatment for radiation dermatitis. In this study, the investigators have designed novel ROS-scavenging nanoenzymes, offering a potential new approach for preventing and treating radiation dermatitis.
This clinical trial aims to evaluate the effectiveness of these novel ROS-scavenging nanoenzymes in preventing radiation dermatitis in patients with head and neck cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a pathological diagnosis of non-metastatic head and neck malignant tumors;
- •Patients deemed suitable for high-dose radiotherapy, either as a primary treatment or as postoperative treatment following surgical resection.
排除标准
- •Eastern Cooperative Oncology Group performance status of >2;
- •Pre-existing skin rash, ulceration or open wound in the treatment area;
- •Inflammatory or connective tissue disorder of the skin;
- •History of head and neck radiotherapy.
研究组 & 干预措施
ROS-scavenging Nanoenzymes
干预措施: ROS-scavenging Nanoenzymes (Drug)
Standard of care
干预措施: Standard of care (Behavioral)
结局指标
主要结局
The incidence of grade 2 or higher radiation dermatitis
时间窗: From the start of radiotherapy to 2 weeks after completion of radiotherapy.
Patients are assessed weekly for radiation dermatitis by an experienced radiation oncology nurse according to the Radiation Therapy Oncology Group (RTOG) criteria.
次要结局
- The maximum skin toxicity(From the start of radiotherapy to 2 weeks after completion of radiotherapy.)
研究者
Xingchen Peng
Professor
West China Hospital