Ignite Creation Date:
2024-05-06 @ 10:54 AM
Last Modification Date:
2024-10-26 @ 12:37 PM
Study NCT ID:
NCT03387774
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-01-31
First Post:
2017-12-02
Brief Title:
Efficacy of Ulinastatin for Reducing Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma Patients
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
A Phase 3 Open Label Multicenter Randomized Controlled Clinical Trial to Evaluate the Efficacy of Ulinastatin in the Reduction of Acute Oral Mucositis Caused by Concurrent ChemoradiotherapyCCRT for Patients With Localregionally Advanced Nasopharyngeal Carcinoma NPC
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-01
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:
UTI-RTOM-NPC
Brief Summary:
This is a phase 3 open-label multicenter randomized controlled phase III clinical trial The purpose of this study is to evaluate the efficacy of ulinastatin a kind of protease inhibitor in the treatment of radiation-induced acute oral mucositis in localregionally advanced nasopharyngeal carcinomaNPC patients treated with concurrent chemoradiotherapyCCRT To Explore a new and efficient way to reduce the incidence and severity of radiation-induced acute oral mucositis
Detailed Description:
Radiation-induced acute oral mucositis RTOM in Nasopharyngeal Carcinoma NPC patients treat with concurrent chemoradiotherapy CCRT is common Currently there is no effective treatment for RTOM Ulinastatin is a kind of natural anti-inflammatory substance And this substance is insufficient when the bodys inflammatory response is strongly There are a series of studies have confirmed the efficacy and safety of ulinastatin in the treatment of bodys inflammatory response From the observation of our previous clinical practice we found that ulinastatin can relieve the severity of RTOM The present study is undertaken to evaluate the efficacy of ulinastatin in the treatment of RTOM in localregionally advanced NPC patients treated with CCRT
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