Effect of Standard Nutrition Therapy on Nutritional Status and Prognosis in Locoregionally Advanced Nasopharyngeal Carcinoma Patients With Malnutrition: A Prospective, Multicenter, Phase III Randomized Control Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 266
- 试验地点
- 1
- 主要终点
- The incidence of IBW%
研究概览
简要总结
This is a multicenter, randomized controlled, phase III clinical trial. The purpose of this study is to evaluate the efficacy of standard nutrition treatment versus conventional nutrition treatment in local advanced nasopharyngeal carcinoma patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III);
- •All genders，range from 18～65 years old;
- •Karnofsky performance status(KPS) ≥ 80;
- •Clinical stage III~IVa(AJCC/UICC 8th);
- •Without significant digestive system disease，nutritional and metabolic diseases or endocrine disease
- •Without significant cardiac，respiratory，kidney or liver disease;
- •Not received radiotherapy, chemotherapy and other anti-tumor treatment(including immunotherapy);
- •White blood cell(WBC) count ≥ 4×109/L, neutrophile granulocyte(NE) count ≥ 1.5×109/L, Hemoglobin(HGB) ≥ 9g/L, platelet(PLT) count ≥ 100×109/L
- •Total bilirubin(TBIL)、alanine aminotransferase (ALT) or aspartate aminotransferase(AST) < 2.5×upper limit of normal(ULN);
- •Adequate renal function: BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
- •No contraindications to chemotherapy or radiotherapy;
- •Inform consent form;
排除标准
- •Have some PEG/PEJ contraindications, such as coagulopathy, recent anticoagulant medications and aspirin, gastric ulcer or history of gastric bleeding, portal hypertension combined with abdominal and esophageal fundal varices, pyloric obstruction due to residual stomach under the costal arch after various major gastrectomy or various reasons;
- •Distance metastases;
- •Have or are suffering from other malignant tumors;
- •Participating in other clinical trials;
- •Drug or alcohol addition;
- •Do not have full capacity for civil acts;
- •Mental disorder;
- •Pregnancy or lactation;
- •Severe complication, eg, uncontrolled hypertension;
研究组 & 干预措施
Standard nutrition therapy
Dynamic nutrition assessment will be performed to patients. If malnutrion happened, patients would receive oral nutritional supplements (ONS) first, then feeded with nasal feeding tube or PEG when ONS wasn't enough. If all the these enteral nutrition methods couldn't make up for patient's nutritional deficiencies, parenteral nutrition would be considered.
干预措施: Standardized nutrition therapy (Other)
Standard nutrition therapy
Dynamic nutrition assessment will be performed to patients. If malnutrion happened, patients would receive oral nutritional supplements (ONS) first, then feeded with nasal feeding tube or PEG when ONS wasn't enough. If all the these enteral nutrition methods couldn't make up for patient's nutritional deficiencies, parenteral nutrition would be considered.
干预措施: Intensity Modulated Radiation Therapy (Radiation)
Conventional nutrition therapy
Dynamic nutrition assessment will be performed to patients throughout whole treatment, and symptomatic treatment would be performed if needed.
干预措施: Intensity Modulated Radiation Therapy (Radiation)
Standard nutrition therapy
Dynamic nutrition assessment will be performed to patients. If malnutrion happened, patients would receive oral nutritional supplements (ONS) first, then feeded with nasal feeding tube or PEG when ONS wasn't enough. If all the these enteral nutrition methods couldn't make up for patient's nutritional deficiencies, parenteral nutrition would be considered.
干预措施: Cisplatin (Drug)
Conventional nutrition therapy
Dynamic nutrition assessment will be performed to patients throughout whole treatment, and symptomatic treatment would be performed if needed.
干预措施: Cisplatin (Drug)
结局指标
主要结局
The incidence of IBW%
时间窗: 2 months
To observe the changes and differences in the incidence of the actual weight/ideal weight (IBW%) less than 90% during the treatment of the two groups of patients
次要结局
- The incidence of WL、UBW% and BMI(36 months)
- Number of Participants With Abnormal Laboratory Values(36 months)
- Overall survival(36 months)
- Progression free survival(36 months)
- Locoregional recurrence free survival(36 months)
- Distant metastasis free survival(36 months)
- Nutrition screening and evaluation(36 months)
- Quality of life: EuroQoL 5 dimension(36 months)
- Acute toxicities(through study completion, an average of 2 months)
- Late toxicity(36 months)
研究者
Zhao Chong
Prof.
Sun Yat-sen University