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.
1\. Experimental group: NST whole-course intervention
1. 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. 2. Radiotherapy 3. 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:
1. Body weight and body mass index (BMI) 2. Quality of life score (EORTCQLQ-C30) 3. Nutritional status 4. 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
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);
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;
Parallel
Nutritional Support Team
Dietary supplementNutritionists 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 intake cannot 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.
Docetaxel
Drug60-75 mg/m2, d1, at least 2 cycles in parallel with radiotherapy
cisplatin
Drugcisplatin 25mg/m2 d1-3, 21-28d/cycle. at least 2 cycles in parallel with radiotherapy
Radiotherapy
Radiationimage-guided intensity-modulated radiotherapy (IGRT) or intensity-modulated radiotherapy (IMRT); Irradiation targets include primary lesions, clinical targets, positive lymph nodes, and lymph node drainage areas. Dose splitting/prescription dose, 95% volume PGTV-T60-66Gy/30-35 times, PGTV-N 60-66Gy/30-35 times, PCTV-T 46-50Gy/23-25 times, PCTV-N46-50Gy/23-25 times.
Body weight and body mass index (BMI)
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
Quality of life score
EORTCQLQ-C30，EORTC:The European O-rganization for Reasearch and Treatment of Cancer)，QOL-C30 (Quality of Life Questionnare-Core 30，Assessments are conducted every two weeks on Fridays of the second week
hemoglobin
Compare the numerical changes of hemoglobin every two weeks
serum albumin
Compare the numerical changes of serum albumin every two weeks
ORR
Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission
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