ROS-scavenging Amino Acid-derived Lipids for the Prevention and 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
- 40
- 试验地点
- 1
- 主要终点
- The incidence of radiation dermatitis
研究概览
简要总结
Radiation dermatitis is a common complication in head and neck squamous cell carcinoma patients receiving radiotherapy. This study proposes an ROS-scavenging amino acid-based nanolipid to prevent oxidative skin damage. A multicenter randomized trial will evaluate its safety and efficacy in reducing dermatitis severity and improving treatment continuity.
详细描述
Radiation dermatitis represents one of the most frequent complications in patients with head and neck squamous cell carcinoma (including nasopharyngeal carcinoma) undergoing radiotherapy, often leading to treatment interruption and compromised therapeutic outcomes. To address the limitations of current preventive strategies, this project proposes a novel amino acid-based lipid formulation designed to scavenge reactive oxygen species (ROS). Leveraging FDA-approved natural amino acids and engineered into a unique nanoliposomal structure, this formulation enables efficient delivery of antioxidative agents, effectively neutralizing excess ROS generated during radiotherapy while activating endogenous antioxidant signaling pathways, thereby mitigating oxidative damage to dermal cells. A multicenter randomized controlled clinical trial will be conducted to systematically evaluate the efficacy and safety of this intervention in reducing the incidence and severity of radiation dermatitis. This study will provide a clinically viable and safe prophylactic strategy, enhancing patients' quality of life and ensuring uninterrupted radiotherapy, with significant translational and societal implications.
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;
- •Known allergy to trolamine or amino acid;
- •Inflammatory or connective tissue disorder of the skin;
- •History of head and neck radiotherapy.
研究组 & 干预措施
Amino acid-derived lipids
干预措施: Amino acid-derived lipids (Drug)
standard of care
干预措施: standard of care (Behavioral)
结局指标
主要结局
The incidence of 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
