RecruitingNot ApplicableNCT05800054

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

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

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

210 participants

Start Date

Jan 1, 2021

Study Type

INTERVENTIONAL

Conditions

Esophageal Neoplasms Adverse Drug Event

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

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether a structured nutrition support program helps people with esophageal cancer who are undergoing radiation and chemotherapy maintain their nutritional health and reduce side effects from treatment. **You may be eligible if:** - You are between 18 and 75 years old - You have been diagnosed with esophageal squamous cell carcinoma (a type of esophageal cancer) - You have Stage II or III esophageal cancer that will be treated without surgery - Your cancer has not spread to distant organs - You are showing signs of malnutrition or nutritional risk - Your liver, kidney, and blood counts are within acceptable ranges - You are expected to live at least 6 months **You may NOT be eligible if:** - You have no nutritional problems (well-nourished) - Your intestines are severely impaired or you cannot tolerate tube feeding - You have severe vomiting, gastrointestinal bleeding, or bowel obstruction - You have already received radiation, chemotherapy, or targeted therapy for this cancer - You have had another cancer in the last 5 years - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIETARY_SUPPLEMENTNutritional 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.

DRUGDocetaxel

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

DRUGcisplatin

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

RADIATIONRadiotherapy

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.