Effect of NST Whole-course Nutritional Management on Nutritional Status and Adverse Reactions in Patients With Esophageal Cancer Undergoing Concurrent Chemoradiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Body weight and body mass index (BMI)
研究概览
简要总结
This study is a randomized, open, parallel controlled clinical trial. The main purpose of this study was to compare the changes in body weight/body mass index (BMI) before and after treatment between the two groups of patients with NST full-course nutritional management and without NST full-course nutritional management.
The secondary objective was to compare the quality of life, nutritional status, immune function and inflammatory response, adverse reactions of radiotherapy and chemotherapy, and short-term/long-term efficacy between the two groups.
The treatment plan was: esophageal cancer with routine nutrition guidance as the control group, and the NST whole-process intervention guidance as the experimental group.
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Experimental group: NST whole-course intervention
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Nutritionists formulate nutritional programs and manage them in a refined manner. On the basis of the patient's natural diet (food and homogenate meal), enteral nutritional preparations or parenteral nutritional supplements are given according to the patient's gastrointestinal obstruction, dietary structure, and food intake. Energy 30-35kcal/kg/d, protein 1.2-1.5g/kg/d. Enteral nutrition administration route: oral or tube feeding or ostomy, oral feeding is preferred; severe obstruction of eating or oral can not meet the target nutrition, choose tube feeding or ostomy. When it is expected that enteral nutrition cannot meet 60% of the target energy requirement for 3 to 5 days, choose parenteral nutrition. The enteral nutritional preparation adopts the whole protein enteral nutritional preparation Nengquan, and/or the tumor nutritional preparation Ruineng, and/or whey protein powder.
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Radiotherapy
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Chemotherapy 2. Control group: routine nutrition guidance for esophageal cancer
(1) Nutritional therapy: The nutritional program was the same as that of the experimental group, and the patients performed it themselves.
(2) Concurrent chemoradiotherapy: the same as the experimental group.
Efficacy evaluation:
- Body weight and body mass index (BMI)
- Quality of life score (EORTCQLQ-C30)
- Nutritional status
- Immune function and inflammatory response (total lymphocytes, CRP, IL-6)
(4) Intestinal mucosal barrier and intestinal flora (5) Adverse reactions of radiotherapy and chemotherapy (6) Short-term/long-term efficacy (5) Evaluation of treatment side effects (6) Short-term/long-term efficacy
详细描述
This study is a randomized, open, parallel controlled clinical trial. The main purpose of this study was to compare the changes in body weight/body mass index (BMI) before and after treatment between the two groups of patients with NST full-course nutritional management and without NST full-course nutritional management.
The secondary objective was to compare the quality of life, nutritional status, immune function and inflammatory response, adverse reactions of radiotherapy and chemotherapy, and short-term/long-term efficacy between the two groups.
The treatment plan was: esophageal cancer with routine nutrition guidance as the control group, and the NST whole-process intervention guidance as the experimental group.
-
Experimental group: NST whole-course intervention
-
Nutritionists formulate nutritional programs and manage them in a refined manner. On the basis of the patient's natural diet (food and homogenate meal), enteral nutritional preparations or parenteral nutritional supplements are given according to the patient's gastrointestinal obstruction, dietary structure, and food intake. Energy 30-35kcal/kg/d, protein 1.2-1.5g/kg/d. Enteral nutrition administration route: oral or tube feeding or ostomy, oral feeding is preferred; severe obstruction of eating or oral can not meet the target nutrition, choose tube feeding or ostomy. When it is expected that enteral nutrition cannot meet 60% of the target energy requirement for 3 to 5 days, choose parenteral nutrition. The enteral nutritional preparation adopts the whole protein enteral nutritional preparation Nengquan, and/or the tumor nutritional preparation Ruineng, and/or whey protein powder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sign the informed consent; must have good compliance with the treatment plan and follow-up.
- •No gender restriction, but age between 18 and 75 years old;
- •Cytological or histological is confirmed esophageal squamous cell carcinoma;
- •Non-surgical treatment of stage II-III primary esophageal cancer (except biopsy);
- •The primary tumor can be evaluated;
- •No distant organ metastasis;
- •PG-SGA score B (2~8) or C (≥9);
- •KPS score ≥ 70 points, ECOG physical condition score 0-1 points;
- •The function of major organs (bone marrow, liver, kidney function) 7 days before treatment, meet the following criteria: Blood routine examination standards (without blood transfusion within 14 days):
- •Hemoglobin (HB) ≥ 100g/L;
- •White blood cells (WBC) ≥ 4×109/L; Absolute neutrophil count (ANC) ≥1.5×109/L;
- •Platelet (PLT) ≥ 100×109/L.
- •The biochemical examination shall meet the following standards:
- •Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);
- •Alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 1.5 times ULN;
- •Serum creatinine (Cr) ≤ 1.5 times ULN or creatinine clearance rate (CCr) ≥ 60ml/min.
- •Expected survival ≥ 6 months.
排除标准
- •No malnutrition or nutritional risk; PG-SGA score of A;
- •Severely impaired intestinal function, or intolerance of enteral nutrition;
- •Severe vomiting, gastrointestinal bleeding, intestinal obstruction;
- •Patients with very severe malnutrition cannot tolerate radiotherapy and chemotherapy;
- •The primary tumor or lymph node has received radiotherapy, chemotherapy or targeted therapy;
- •Suffering from other malignant tumors within 5 years (except for completely cured cervical carcinoma in situ or skin basal cell carcinoma);
- •Subjects who have received other drug trials within the past month;
- •Those with severe allergic history or idiosyncratic constitution;
- •Those with a history of severe lung or heart disease;
- •Serious comorbidities, such as uncontrolled hypertension, heart failure, etc.;
- •Pregnant or breastfeeding women;
- •Currently or planning to participate in other clinical trials;
- •Refusal or inability to sign the informed consent form to accept participation in the trial.
研究组 & 干预措施
NST intervenes throughout the process
- Nutritionists formulate nutritional programs and manage them in a refined manner.
The nutritionist urges the patient to report daily to ensure that the patient's energy and protein are in place 2. Radiotherapy 3. chemotherapy
干预措施: Nutritional Support Team (Dietary Supplement)
NST intervenes throughout the process
- Nutritionists formulate nutritional programs and manage them in a refined manner.
The nutritionist urges the patient to report daily to ensure that the patient's energy and protein are in place 2. Radiotherapy 3. chemotherapy
干预措施: Docetaxel (Drug)
NST intervenes throughout the process
- Nutritionists formulate nutritional programs and manage them in a refined manner.
The nutritionist urges the patient to report daily to ensure that the patient's energy and protein are in place 2. Radiotherapy 3. chemotherapy
干预措施: cisplatin (Drug)
NST intervenes throughout the process
- Nutritionists formulate nutritional programs and manage them in a refined manner.
The nutritionist urges the patient to report daily to ensure that the patient's energy and protein are in place 2. Radiotherapy 3. chemotherapy
干预措施: Radiotherapy (Radiation)
Routine nutrition guidance group for esophageal cancer
- Patients perform their own nutrition regimen, and the nutritionist is not involved in management
- Radiotherapy
- chemotherapy
干预措施: Docetaxel (Drug)
Routine nutrition guidance group for esophageal cancer
- Patients perform their own nutrition regimen, and the nutritionist is not involved in management
- Radiotherapy
- chemotherapy
干预措施: cisplatin (Drug)
Routine nutrition guidance group for esophageal cancer
- Patients perform their own nutrition regimen, and the nutritionist is not involved in management
- Radiotherapy
- chemotherapy
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Body weight and body mass index (BMI)
时间窗: up to 3 years
BMI = weight ÷ height2. (Unit of weight: kg; Height unit: meters),During treatment: Body weight was recorded daily and BMI was recorded weekly,BMI values are recorded every Friday
次要结局
- hemoglobin(up to 3 years)
- serum albumin(up to 3 years)
- Quality of life score(up to 3 years)
- ORR(through study completion, an average of 36 month)