Effect of Oral Nutritional Supplements From the Beginning of Radiotherapy on Body Weight Loss of Patients With Nasopharyngeal Carcinoma and Its Cost-Utility Analysis: A Prospective Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 236
- 试验地点
- 13
- 主要终点
- Incidence of weight loss > 5%
研究概览
简要总结
Concurrent chemoradiotherapy(CCRT) is the principal treatment for nasopharyngeal carcinoma(NPC). Studies have shown that malnutrition is very common in patients with NPC after chemoradiotherapy. Malnutrition can lead to weight loss, treatment interruption, prolonged stay in hospital, increased treatment costs, reduced tolerance to anti-tumor therapy, reduced quality of life and shortened survival time. Nutritional intervention can improve the nutritional status, reduce treatment-related toxicity and improve the survival of patients with NPC.
The first choice of nutritional intervention is oral nutritional supplements(ONS). Some retrospective studies with small samples have found that early nutritional intervention can reduce weight loss and severe oral mucositis in patients with NPC, compared with late nutritional intervention. Therefore, the investigators proposed the hypothesis that ONS from the beginning of radiotherapy can reduce the nutritional impairment, treatment-related toxicity and treatment costs of patients with NPC, and improve their quality of life. The aim of this multicenter randomized controlled clinical trial is to evaluate the efficacy and cost utility of ONS from the beginning to the end of radiotherapy.
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 70 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;
- •All genders, range from 18-70 years old;
- •Clinical stage II-IVa according to the 8th edition of the Union for International Cancer Control/American Joint Committee on Cancer (UICC/AJCC) staging system;
- •Patient-Generated Subjective Nutrition Assessment (PG-SGA) score ≤8;
- •Main organ functions test should be satisfied the following conditions: (1) Absolute neutrophil count (ANC) ≥1.5×10^9/L; (2) Platelet (PLT) ≥80×10^9/L; (3) Hemoglobin (Hb) ≥90 g/L; (4) Bilirubin < 1.5 times the upper limit of normal value (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times the upper limit of normal value; (5) Creatinine < 1.5 times the upper limit of normal value or creatinine clearance rate >60 ml/min.
排除标准
- •Patients whose energy intake is less than 60% of the target energy requirement for 3 days or more;
- •Have or are suffering from other malignant tumors;
- •Refuse concurrent chemoradiotherapy;
- •With diabetics, galactosemia, or sever metabolic diseases or endocrine diseases;
- •Cannot take oral or enteral nutrition, including intestinal obstruction, severe short bowel syndrome or high output fistula, or with severe digestive system diseases;
- •Known allergic reaction to any component of Abbott®Ensure, or severe allergic constitution;
- •Pregnant or lactating women;
- •With previous or ongoing clinical trials;
- •Refuse to sign inform consent form.
研究组 & 干预措施
Experimental group
In addition to conventional dietary instruction and individualized nutritional counselling, patients were given additional ONS (Abbott®Ensure of 55.8 g tid) from the beginning to the end of radiotherapy.
干预措施: Abbott®Ensure (Dietary Supplement)
Experimental group
In addition to conventional dietary instruction and individualized nutritional counselling, patients were given additional ONS (Abbott®Ensure of 55.8 g tid) from the beginning to the end of radiotherapy.
干预措施: Intensity Modulated Radiation Therapy (Radiation)
Experimental group
In addition to conventional dietary instruction and individualized nutritional counselling, patients were given additional ONS (Abbott®Ensure of 55.8 g tid) from the beginning to the end of radiotherapy.
干预措施: cisplatin (Drug)
Control group
Conventional dietary instruction and individualized nutritional counselling from the beginning to the end of radiotherapy.
干预措施: Intensity Modulated Radiation Therapy (Radiation)
Control group
Conventional dietary instruction and individualized nutritional counselling from the beginning to the end of radiotherapy.
干预措施: cisplatin (Drug)
结局指标
主要结局
Incidence of weight loss > 5%
时间窗: From time of randomization to the date of radiotherapy ends, up to 7 weeks
The percentage of patients whose body weight decreased more than 5% over baseline, body weight (in kilograms) are measured at baseline and weekly during the course of radiotherapy
次要结局
- Days of radiotherapy interruption(During the course of radiotherapy, up to 7 weeks)
- Increment Cost-Utility Ratio (ICUR）(During the course of chemoradiotherapy, up to 7 weeks)
- PG-SGA Score(From time of randomization to the date of radiotherapy ends, up to 7 weeks)
- Incidence of participants with grade ≥3 oral mucositis(During the course of radiotherapy, up to 7 weeks)
- Score of EQ-5D-5L questionnaire(During the course of chemoradiotherapy, up to 7 weeks)
- Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 v3.0 (EORTC QLQ-C30 v3.0)(From time of randomization to the date of radiotherapy ends, up to 7 weeks)
研究者
Jinsheng Hong
Professor
First Affiliated Hospital of Fujian Medical University