Evaluation of Fenofibrate on Radiation-induced Skin Injury

Radiodermatitis Clinical Trial

Official title:

Evaluation of Fenofibrate on Radiation-induced Skin Injury

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03557983
• Other study ID #: SoochowU
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 13, 2018
• Est. completion date: April 13, 2020

Study information

• Verified date: June 2018
• Source: Second Affiliated Hospital of Soochow University
• Contact: Shuyu Zhang, A/Prof.
• Phone: 86+15851417273
• Email: zhang.shuyu[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 13, 2020
• Est. primary completion date: April 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Radiodermatitis

Intervention

Drug:
• Fenofibrate
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.
• Saline
Saline is topically spread three times per day at the irradiated areas for one week.

Locations

Country	Name	City	State
China	????	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

References & Publications (3)

Kim EN, Lim JH, Kim MY, Kim HW, Park CW, Chang YS, Choi BS. PPARa agonist, fenofibrate, ameliorates age-related renal injury. Exp Gerontol. 2016 Aug;81:42-50. doi: 10.1016/j.exger.2016.04.021. Epub 2016 Apr 27. — View Citation

Liu J, Lu C, Li F, Wang H, He L, Hao Y, Chen AF, An H, Wang X, Hong T, Wang G. PPAR-a Agonist Fenofibrate Upregulates Tetrahydrobiopterin Level through Increasing the Expression of Guanosine 5'-Triphosphate Cyclohydrolase-I in Human Umbilical Vein Endothelial Cells. PPAR Res. 2011;2011:523520. doi: 10.1155/2011/523520. Epub 2011 Nov 16. — View Citation

Zhao Q, Cui Z, Zheng Y, Li Q, Xu C, Sheng X, Tao M, Xu H. Fenofibrate protects against acute myocardial I/R injury in rat by suppressing mitochondrial apoptosis as decreasing cleaved caspase-9 activation. Cancer Biomark. 2017 Jul 4;19(4):455-463. doi: 10.3233/CBM-170572. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of skin wound area	Skin wound area was measured by software-based analysis.	3 months
Secondary	Number of participants with treatment-related adverse events as assessed by Fenofibrate	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).	3 months
Secondary	Evaluation of skin injury	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.	2 week
Secondary	Evaluation of skin toxicity of radiotherapy	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.	2 week