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

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

Conditions

• Esophageal Neoplasms
• Adverse Drug Event

Interventions

DIETARY_SUPPLEMENT

Nutritional Support Team

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 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.

DRUG

Docetaxel

60-75 mg/m2, d1, at least 2 cycles in parallel with radiotherapy

DRUG

cisplatin

cisplatin 25mg/m2 d1-3, 21-28d/cycle. at least 2 cycles in parallel with radiotherapy

RADIATION

Radiotherapy

image-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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-01-01

Primary Completion

2024-12-31

Completion

2027-12-31

Countries

• China

Study Locations