Efficacy of Ulinastatin for Reducing Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma Patients

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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 carcinoma(NPC) patients treated with concurrent chemoradiotherapy(CCRT). To Explore a new and efficient way to reduce the incidence and severity of radiation-induced acute oral mucositis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborators: Affiliated Cancer Hospital & Institute of Guangzhou Medical University; Fifth Affiliated Hospital, Sun Yat-Sen University; First People's Hospital of Foshan; People's Hospital of Zhongshan
• Treatments: Urinastatin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.