Ignite Creation Date:
2024-05-06 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 12:47 PM
Study NCT ID:
NCT03557983
Status:
UNKNOWN
Last Update Posted:
2018-06-15
First Post:
2018-05-19
Brief Title:
Evaluation of Fenofibrate on Radiation-induced Skin Injury
Sponsor:
Second Affiliated Hospital of Soochow University
Organization:
Second Affiliated Hospital of Soochow University
Study Overview
Official Title:
Evaluation of Fenofibrate on Radiation-induced Skin Injury
Status:
UNKNOWN
Status Verified Date:
2018-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Fenofibrate is a specific ligand for PPARĪ± 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 PPARĪ± has also shown antioxidant and anti-inflammatory properties Fenofibrate confers cytoprotective effect against myocardial ischemia-reperfusion IR 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 RNSROS 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None