Effect of NST Whole-course Nutritional Management on Nutritional Status and Adverse Reactions in Esophageal Cancer

Esophageal Neoplasms Clinical Trial

Official title: Effect of NST Whole-course Nutritional Management on Nutritional Status and Adverse Reactions in Patients With Esophageal Cancer Undergoing Concurrent Chemoradiotherapy

Status Recruiting

Clinical Trial Summary

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

Clinical Trial Description

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.

Enteral nutrition preparations should choose Nengquan, and the dose of Nengjian: (a) No/mild obstruction, can eat ordinary diet, the food intake is not reduced or less than 1/3 before the disease, and 10-15kcal of Nengjian is given. /kg/d; (b) moderate obstruction, can eat soft food, the food intake is less than 1/3~2/3 before the disease, and can give 15-20kcal/kg/d; (c) severe obstruction, can not Eating, the food intake is reduced by >= 2/3 compared with that before the disease, and can be given 20-25kcal/kg/d of all-vegetarian food; Dosage of whey protein powder: (a) albumin 35~40g/L, supplemented with whey protein powder 10g; (b) albumin 30~35g/L, supplemented with whey protein powder 20g; (c) albumin <30g /L, supplement whey protein powder 30g.

Nutritionists urge patients to report daily to ensure adequate energy and protein supplementation.

2. Radiotherapy: image-guided intensity-modulated radiotherapy (IGRT) or intensity-modulated radiotherapy (IMRT); the irradiation target areas include primary lesions, clinical target areas, positive lymph nodes, and lymph node drainage areas. Dose split/prescribed 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.

3. Chemotherapy: Docetaxel 60-75mg/m2, d1, DDP 25mg/m2 d1-3, 21-28d/cycle. Simultaneous with radiotherapy for at least 2 cycles, after radiotherapy, the choice of whether to continue adjuvant chemotherapy is based on specific circumstances.

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 Statistical methods: All statistical tests were two-sided, and P values < 0.05 were considered statistically significant. Data are presented as x ±s. Quantitative data were analyzed by t test and variance analysis, qualitative data were analyzed by X2 test, and survival data were analyzed by Kaplan Meire method, logrank test, and Cox regression. ;

Related Conditions & MeSH terms

• Adverse Drug Event
• Drug-Related Side Effects and Adverse Reactions
• Esophageal Neoplasms

• NCT number: NCT05800054
• Study type: Interventional
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Xiaolin Ge, PhD
• Phone: 13951818797
• Email: doctorsxl@163.com
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Completion date: December 31, 2027