Clinical trial NCT03387774: Efficacy of Ulinastatin for Reducing Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma Patients
Official title: A Phase 3, Open Label, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Efficacy of Ulinastatin in the Reduction of Acute Oral Mucositis Caused by Concurrent Chemoradiotherapy(CCRT) for Patients With Localregionally Advanced Nasopharyngeal Carcinoma (NPC).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Oral Mucositis (Ulcerative) Due to Radiation
Keywords: Ulinastatin
Radiation-induced acute oral mucositis
Localregionally Advanced Nasopharyngeal Carcinoma
Intensity Modulated Radiation Therapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
name: First People's Hospital of Foshan
name: Fifth Affiliated Hospital, Sun Yat-Sen University
First posted: 2018-01-02
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Incidence of Severe Acute Oral Mucositis (Grade of CTC-AE ≥ 3)
timeFrame: Up to 19 weeks
Secondary outcomes:
measure: Weeks to Onset of Severe Radiation-Induced Acute Oral Mucositis (Grade of CTCAE ≥ 3)
timeFrame: Up to Week 19
measure: Oral Assessment Guide (OAG) Score
timeFrame: Up to 19 weeks
measure: Oral Mucositis Scores by World Health Organization (WHO)
timeFrame: Up to 19 weeks
measure: Rate of Participants With Unplanned Breaks in Radiotherapy
timeFrame: During the 7 weeks for concurrent chemoradiotherapy
measure: Quality of Life with EORTC QLQ-C30
timeFrame: Up to 19 weeks
measure: Karnofsky Performance Status Scale
timeFrame: Up to 19 weeks
measure: Numeric Rating Scale for Pain(NRS scale)
timeFrame: Up to 19 weeks
measure: 3 Months Overall Response Rate
timeFrame: Assessed at 3 months after concurrent chemoradiotherapy
measure: The Adverse events Related to Ulinastatin
timeFrame: Up to 19 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: zhao chong
role: PRINCIPAL_INVESTIGATOR
References: