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

Sun Yat-sen University

Status and phase: Completed; Phase 3

Conditions: Oral Mucositis (Ulcerative) Due to Radiation

Treatments: Radiation: Intensity Modulated Radiation Therapy; Drug: Cisplatin; Drug: Ulinastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT03387774

UTI-RTOM-NPC

Details and patient eligibility

About

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.

Full 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. 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.

Enrollment: 179 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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179 participants in 2 patient groups

Concurrent chemoradiotherapy and ulinastatin

Experimental group

Description:

Concurrent chemoradiotherapy (CCRT) and intravenous drip of ulinastatin, the details are as follows: 1. Intensity modulated radiation therapy combined with concurrent chemotherapy of cisplatin 100mg/m2 on day 1 and day 22 of RT; 2. Ulinastatin through intravenous drip at a dose of one hundred thousand units added to 100 ml of 0.9% normal saline, 3 times every radiation day, until the end of radiotherapy.

Treatment:

Drug: Ulinastatin

Drug: Cisplatin

Radiation: Intensity Modulated Radiation Therapy

Concurrent chemoradiotherapy

Active Comparator group

Description:

Concurrent chemoradiotherapy (CCRT) alone: Intensity modulated radiation therapy combined with concurrent chemotherapy of cisplatin 100mg/m2 on day 1 and day 22 of RT.

Treatment:

Drug: Cisplatin

Radiation: Intensity Modulated Radiation Therapy