Evaluation of Fenofibrate on Radiation-induced Skin Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-13

Study Completion Date

2020-04-13

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Radiodermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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fenofibrate

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

Group Type EXPERIMENTAL

Fenofibrate

Intervention Type 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.

Saline

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

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Saline

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes