Status:
COMPLETED
Efficacy of Ulinastatin for Reducing Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma Patients
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
First People's Hospital of Foshan
Conditions:
Oral Mucositis (Ulcerative) Due to Radiation
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 t...
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. ...
Eligibility Criteria
Inclusion
- Newly histologic diagnosis of nasopharyngeal carcinoma without distant metastasis
- Clinical stage III\~IVa( UICC (Union International Against Cancer) /AJCC (American Joint Committee on Cancer) TNM staging system 8th edition)
- Karnofsky Performance Status Scale between 80-100
- WBC count ≥ 4×109/L，neutrophil differential count≥ 1.5×109/L,Hemoglobin ≥ 90g/L， platelet count ≥ 100×109/L
- ALT or AST ≤2.5×ULN,bilirubin ≤2.5×ULN,Serum creatinine ≤1.5×ULN or Serum creatinine clearance≥60ml/min
- Sign the informed consent.
Exclusion
- Angle of sexual squamous cell carcinomas and basal cell layout, squamous cell carcinomas
- Younger than 18 years old or older than 70 years old
- Pregnancy or lactation
- Severe cerebrovascular disease/canker/psychosis/uncontrolled diabetes
- Have suffered from other tumor or now suffering from other tumor
- Have suffered from oral diseases or salivary gland diseases or mow suffering from oral diseases or salivary gland diseases
- Refuse to give up smoking/drinking/betel chewing
- suffering from other active infection diseases and in need of treatment.
Key Trial Info
Start Date :
January 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2024
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT03387774
Start Date
January 30 2018
End Date
January 31 2024
Last Update
May 16 2025
Active Locations (1)
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1
Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, China