Efficacy of Ulinastatin for Reducing Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma Patients (UTI-RTOM-NPC)

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    Sun Yat-sen University
Updated on 26 February 2022


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.

Condition Oral Mucositis (Ulcerative) Due to Radiation
Treatment cisplatin, Intensity Modulated Radiation Therapy, ulinastatin
Clinical Study IdentifierNCT03387774
SponsorSun Yat-sen University
Last Modified on26 February 2022


Yes No Not Sure

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
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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
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