Efficacy of Ulinastatin for Reducing Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma Patients
Efficacy of Ulinastatin for Reducing Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma Patients
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.
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 body's inflammatory response is strongly. There are a
 series of studies have confirmed the efficacy and safety of ulinastatin in the treatment of
 body's 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.
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.