Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06410443
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-04-30
Brief Title:
Efficacy and Safety of Local Glucocorticoids for the Treatment of Acute Radiation-Induced Intestinal Injury
Sponsor:
General Hospital of Shenyang Military Region
Organization:
General Hospital of Shenyang Military Region
Study Overview
Official Title:
Efficacy and Safety of Local Glucocorticoids for the Treatment of Acute Radiation-Induced Intestinal Injury A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
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:
Due to the increasing number and prolonged survival of malignant tumor patients treated with radiotherapy the complication such as acute radiation-induced intestinal injury has become increasingly significant Glucocorticoids may play a therapeutic role by regulating the inflammatory response in patients with acute radiation-induced intestinal injury However the conclusions of related studies were controversial
Detailed Description:
A total of 60 patients with acute radiation-induced intestinal injury will be enrolled They will be randomly assigned at a 11 ratio into glucocorticoid group and standard treatment group The primary endpoint is the recovery and improvement of acute radiation-induced intestinal injury The secondary study endpoints include the recurrence and aggravation of radiation-induced intestinal injury and adverse events
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