Radiodermatitis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGFenofibrate
Fenofibrate is dissolved in Saline and topically spread three times per day at the irradiated areas, with a concentration of 400 μg/mL for week.
DRUGSaline
Saline is topically spread three times per day at the irradiated areas for one week.
Sponsors
Second Affiliated Hospital of Soochow University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* 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).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of skin wound area | 3 months | Skin wound area was measured by software-based analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by Fenofibrate | 3 months | Toxicity of Fenofibrate was graded using the NCI Common Terminology Criteria for Adverse Events v. 3.0. Any adverse event. Grade 1 attributed to fenofibrate was considered dose-limiting toxicity (DLT). |
| Evaluation of skin injury | 2 week | Skin toxicity of radiotherapy was evaluated every day, once radiation began. Fenofibrate administration was given immediately when Grade 1 dermatitis occurred, and then dermatitis was recorded weekly. The score at the end of radiotherapy was the one of the last week of radiotherapy. The evaluation continued until 2 weeks after the end of radiotherapy with two approaches. The standard was the RTOG score defined by the observers. |
| Evaluation of skin toxicity of radiotherapy | 2 week | Skin toxicity of radiotherapy was evaluated every day, once radiation began. Fenofibrate administration was given immediately when Grade 1 dermatitis occurred, and then dermatitis was recorded weekly. The score at the end of radiotherapy was the one of the last week of radiotherapy. The evaluation continued until 2 weeks after the end of radiotherapy with two approaches. Patient-reported symptom scores was adapted from the Skin Toxicity Assessment Tool as pain, burning, itching, pulling and tenderness in the treatment area. |
Countries
China
Contacts
Primary ContactShuyu Zhang, A/Prof.
Outcome results
None listed