Evaluation of Fenofibrate on Radiation-induced Skin Injury

NCT03557983 | Unknown DMC

• 1 other identifier: SoochowU
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiodermatitis

Outcome Measures

Primary Outcomes (1)

• Measurement of skin wound area

  Skin wound area was measured by software-based analysis.

  3 months

Secondary Outcomes (3)

• 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

Study Arms (2)

fenofibrate

EXPERIMENTAL

Fenofibrate should be topically spread three times per day at the irradiated areas, with a concentration of 400 μg/mL for week.

Drug: Fenofibrate

Saline

PLACEBO COMPARATOR

Saline is topically spread three times per day for one week.

Drug: Saline

Interventions

Fenofibrate DRUG

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.

fenofibrate

Saline DRUG

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

Saline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Soochow University: lead

Study Sites (1)

苏州大学

Suzhou, Jiangsu, 215123, China

Location

Related Publications (3)

• 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.

  PMID: 28582851 BACKGROUND

• Kim EN, Lim JH, Kim MY, Kim HW, Park CW, Chang YS, Choi BS. PPARalpha 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.

  PMID: 27130813 BACKGROUND

• Liu J, Lu C, Li F, Wang H, He L, Hao Y, Chen AF, An H, Wang X, Hong T, Wang G. PPAR-alpha 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.

  PMID: 22190909 BACKGROUND

MeSH Terms

Conditions

Radiodermatitis

Interventions

Fenofibrate; Sodium Chloride

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Shuyu Zhang, A/Prof.

  Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuyu Zhang, A/Prof.

CONTACT

86+15851417273; zhang.shuyu@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Shuyu Zhang Associate Professor

Study Record Dates

• First Submitted: May 19, 2018
• First Posted: June 15, 2018
• Study Start: June 13, 2018
• Primary Completion: April 13, 2020
• Study Completion: April 13, 2020
• Last Updated: June 15, 2018

Record last verified: 2018-06

Locations

CN (1)