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Evaluation of Fenofibrate on Radiation-induced Skin Injury

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ClinicalTrials.gov Identifier: NCT03557983
Recruitment Status : Unknown
Verified June 2018 by zhangshuyu, Second Affiliated Hospital of Soochow University.
Recruitment status was:  Not yet recruiting
First Posted : June 15, 2018
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
zhangshuyu, Second Affiliated Hospital of Soochow University

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.

Condition or disease Intervention/treatment Phase
Radiodermatitis Drug: Fenofibrate Drug: Saline Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of Fenofibrate on Radiation-induced Skin Injury
Estimated Study Start Date : June 13, 2018
Estimated Primary Completion Date : April 13, 2020
Estimated Study Completion Date : April 13, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Fenofibrate

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

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




Primary Outcome Measures :
  1. Measurement of skin wound area [ Time Frame: 3 months ]
    Skin wound area was measured by software-based analysis.


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by Fenofibrate [ Time Frame: 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).

  2. Evaluation of skin injury [ Time Frame: 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.

  3. Evaluation of skin toxicity of radiotherapy [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03557983


Contacts
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Contact: Shuyu Zhang, A/Prof. 86+15851417273 zhang.shuyu@hotmail.com

Locations
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China, Jiangsu
苏州大学
Suzhou, Jiangsu, China, 215123
Contact: Shuyu Zhang, A/Prof.    86+15851417273    zhang.shuyu@hotmail.com   
Sponsors and Collaborators
Second Affiliated Hospital of Soochow University
Investigators
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Principal Investigator: Shuyu Zhang, A/Prof. Soochow University
Publications:
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Responsible Party: zhangshuyu, Shuyu Zhang Associate Professor, Second Affiliated Hospital of Soochow University
ClinicalTrials.gov Identifier: NCT03557983    
Other Study ID Numbers: SoochowU
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Radiodermatitis
Dermatitis
Skin Diseases
Radiation Injuries
Wounds and Injuries
Fenofibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents