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

NCT05800054 | Recruiting

• 1 other identifier: GXL-001
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.Radiotherapy
3. 3.Chemotherapy 2. Control group: routine nutrition guidance for esophageal cancer
4. 4.Body weight and body mass index (BMI)
5. 5.Quality of life score (EORTCQLQ-C30)
6. 6.Nutritional status
7. 7.Immune function and inflammatory response (total lymphocytes, CRP, IL-6)

Conditions

Esophageal Neoplasms; Adverse Drug Event

Outcome Measures

Primary Outcomes (1)

• 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

  up to 3 years

Secondary Outcomes (4)

• Quality of life score

  up to 3 years

• hemoglobin

  up to 3 years

• serum albumin

  up to 3 years

• ORR

  through study completion, an average of 36 month

Study Arms (2)

NST intervenes throughout the process

EXPERIMENTAL

1. 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

Dietary Supplement: Nutritional Support Team; Drug: Docetaxel; Drug: cisplatin; Radiation: Radiotherapy

Routine nutrition guidance group for esophageal cancer

EXPERIMENTAL

1. Patients perform their own nutrition regimen, and the nutritionist is not involved in management 2. Radiotherapy 3. chemotherapy

Drug: Docetaxel; Drug: cisplatin; Radiation: Radiotherapy

Interventions

Nutritional Support Team DIETARY_SUPPLEMENT

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.

Also known as: taixinsheng

NST intervenes throughout the process

Docetaxel DRUG

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

Also known as: chemotherapy

NST intervenes throughout the process; Routine nutrition guidance group for esophageal cancer

cisplatin DRUG

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

Also known as: chemotherapy

NST intervenes throughout the process; Routine nutrition guidance group for esophageal cancer

Radiotherapy RADIATION

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.

NST intervenes throughout the process; Routine nutrition guidance group for esophageal cancer

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Drug-Related Side Effects and Adverse Reactions

Interventions

Docetaxel; Drug Therapy; Cisplatin; Radiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Xiaolin Ge, PhD

CONTACT

13951818797; doctorsxl@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2022
• First Posted: April 5, 2023
• Study Start: January 1, 2021
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 5, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)