Efficacy of Ulinastatin for Reducing Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma… (NCT03387774) | Clinical Trial Compass
CompletedPhase 3
Efficacy of Ulinastatin for Reducing Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma Patients
China179 participantsStarted 2018-01-30
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Incidence of Severe Acute Oral Mucositis (Grade of CTC-AE ≥ 3)