ROS-Scavenging Nanozyme Combined With Near-Infrared Thermotherapy for the Amelioration of Grade III Radiation Dermatitis in Patients With Head and Neck Cancer
概览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- The incidence of grade 3 radiation dermatitis
概览
简要总结
Severe radiation dermatitis remains a challenging complication in head and neck cancer with limited treatment options; this study aims to evaluate a novel Prussian blue-based nanozyme combined with near-infrared thermotherapy to promote effective healing of Grade III lesions.
详细描述
Radiation dermatitis is a common and challenging complication for patients undergoing radiotherapy, especially those with head and neck cancer. Currently, there are limited effective clinical treatments available for managing severe (Grade III) radiation-induced skin damage.
This study aims to explore a novel and safe treatment strategy for alleviating Grade III radiation dermatitis. The investigators use Prussian blue, an FDA-approved compound known for its reactive oxygen species (ROS) scavenging ability, formulated into a nanozyme that targets oxidative stress at the injury site. When combined with near-infrared (NIR) thermotherapy, this approach promotes faster skin repair and reduces inflammation.
This study's goal is to provide an effective and patient-friendly therapeutic option that accelerates healing and improves quality of life for individuals suffering from severe radiation dermatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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;
- •Known allergy to trolamine or prussian blue;
- •Inflammatory or connective tissue disorder of the skin;
- •History of head and neck radiotherapy.
研究组 & 干预措施
Photo-responsive nanozyme
The nanozyme scavenges ROS at the site of dermatitis and simultaneously responds to NIR light to generate mild heat, thereby promoting the healing of radiation-induced skin injury.
干预措施: Photo-responsive nanozyme (Drug)
结局指标
主要结局
The incidence of grade 3 radiation dermatitis
时间窗: From the onset of Grade III dermatitis to two weeks after the 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
- Bacterial load at the site of dermatitis(From the first administration of drug treatment through study completion, an average of 1 month.)
研究者
Xingchen Peng
professor
West China Hospital