Evaluation of Fenofibrate on Radiation-induced Skin Injury
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Measurement of skin wound area
研究概览
简要总结
Fenofibrate is a specific ligand for PPARα, which has been used for the treatment of hypercholesterolemia, hypertriglyceridemia, diabetes and cardiovascular diseases for long time. Fenofibrate reduces low-density lipoprotein (LDL), very low density lipoprotein (VLDL) and triglyceride levels, while increases high-density lipoprotein (HDL) levels. PPARα has also shown antioxidant and anti-inflammatory properties. Fenofibrate confers cytoprotective effect against myocardial ischemia-reperfusion (I/R) injury in rats by suppressing cell apoptosis and ameliorates age-related renal injury through the activation of AMPK and SIRT1 signaling. However, the safety and effectiveness of fenofibrate on the progression of radiation-induced skin injury remain unknown. The purpose of this study is to determine whether topical application of fenofibrate is safe and effective for radiation-induced skin injury.
详细描述
Radiation-induced skin injury is a significant side effect of ionizing radiation delivered to the skin during cancer treatment as well as a result of other exposure to radiation. The skin is one of radiosensitive organ systems in human body because it is a continuously renewing organ containing rapidly proliferating and maturing cells. Ionizing radiation promotes reactive nitrogen and oxygen species (RNS/ROS) production due to radiolysis of water and direct ionization of target molecules, which result in oxidative damage and skin injuries. It is considered that ~95 % of cancer patients receiving radiation therapy will develop some form of radiodermatitis, including erythema, dry desquamation, and moist desquamation. Radiation-induced skin injury negatively affects the process of radiotherapy and the quality of patients' life. Despite substantial improvements in radiation technology, radiation-induced skin toxicity is still a concerning problem. The purpose of this study is to determine whether topical application of fenofibrate is safe and effective for radiation-induced skin injury.
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
- Single (Participant)
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
- 是
入选标准
- •Eligible patients had to have a pathologically proven cancer with a planned course of radiotherapy.
- •Normal haematological function (granulocyte count > 1.5 X 109 cells per litre, platelet count > 100 X 109 cells per litre and haemoglobin > 100 g/L) and organ function (creatinine clearance > 50 mL/min) and aspartate aminotransferase/alanine aminotransferase < 2.5 of upper normal limit).
排除标准
- •The presence of rash or unhealed wound in the radiation field, known allergy or hypersensitivity to fenofibrate, pregnancy or lactation, history of/current connective tissue disorder and prior radiation to the thorax.
研究组 & 干预措施
fenofibrate
Fenofibrate should be topically spread three times per day at the irradiated areas, with a concentration of 400 μg/mL for week.
干预措施: Fenofibrate (Drug)
Saline
Saline is topically spread three times per day for one week.
干预措施: Saline (Drug)
结局指标
主要结局
Measurement of skin wound area
时间窗: 3 months
Skin wound area was measured by software-based analysis.
次要结局
- Number of participants with treatment-related adverse events as assessed by Fenofibrate(3 months)
- Evaluation of skin injury(2 week)
- Evaluation of skin toxicity of radiotherapy(2 week)
研究者
zhangshuyu
Shuyu Zhang Associate Professor
Second Affiliated Hospital of Soochow University