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

Primary Purpose

Esophageal Neoplasms, Adverse Drug Event

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Nutritional Support Team
Docetaxel
cisplatin
Radiotherapy
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Esophageal Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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; Serum creatinine (Cr) ≤ 1.5 times ULN or creatinine clearance rate (CCr) ≥ 60ml/min. Expected survival ≥ 6 months. Exclusion Criteria: 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.

Sites / Locations

  • The First Affiliated Hospital of Nanjing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

NST intervenes throughout the process

Routine nutrition guidance group for esophageal cancer

Arm Description

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 Radiotherapy chemotherapy

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 14, 2022
Last Updated
March 23, 2023
Sponsor
The First Affiliated Hospital with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05800054
Brief Title
Effect of NST Whole-course Nutritional Management on Nutritional Status and Adverse Reactions in Esophageal Cancer
Official Title
Effect of NST Whole-course Nutritional Management on Nutritional Status and Adverse Reactions in Patients With Esophageal Cancer Undergoing Concurrent Chemoradiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 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. Radiotherapy 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: Body weight and body mass index (BMI) Quality of life score (EORTCQLQ-C30) Nutritional status 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
Detailed 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 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. 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. 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 Nutritional therapy: The nutritional program was the same as that of the experimental group, and the patients performed it themselves. Concurrent chemoradiotherapy: the same as the experimental group. Efficacy evaluation: Body weight and body mass index (BMI) Quality of life score (EORTCQLQ-C30) Nutritional status 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Neoplasms, Adverse Drug Event

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NST intervenes throughout the process
Arm Type
Experimental
Arm Description
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 Radiotherapy chemotherapy
Arm Title
Routine nutrition guidance group for esophageal cancer
Arm Type
Experimental
Arm Description
Patients perform their own nutrition regimen, and the nutritionist is not involved in management Radiotherapy chemotherapy
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutritional Support Team
Other Intervention Name(s)
taixinsheng
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
chemotherapy
Intervention Description
60-75 mg/m2, d1, at least 2 cycles in parallel with radiotherapy
Intervention Type
Drug
Intervention Name(s)
cisplatin
Other Intervention Name(s)
chemotherapy
Intervention Description
cisplatin 25mg/m2 d1-3, 21-28d/cycle. at least 2 cycles in parallel with radiotherapy
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body weight and body mass index (BMI)
Description
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
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
Quality of life score
Description
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
Time Frame
up to 3 years
Title
hemoglobin
Description
Compare the numerical changes of hemoglobin every two weeks
Time Frame
up to 3 years
Title
serum albumin
Description
Compare the numerical changes of serum albumin every two weeks
Time Frame
up to 3 years
Title
ORR
Description
Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission
Time Frame
through study completion, an average of 36 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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; Serum creatinine (Cr) ≤ 1.5 times ULN or creatinine clearance rate (CCr) ≥ 60ml/min. Expected survival ≥ 6 months. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaolin Ge, PhD
Phone
13951818797
Email
doctorsxl@163.com
Facility Information:
Facility Name
The First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaolin Ge, PhD
Phone
13951818797
Email
doctorsxl@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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