Clinical Study on Nutrition Intervention in Patients With Esophageal and Gastric Cancer Treated With Chemotherapy

Clinical Study on Nutrition Intervention to Improve Nutrition and Quality of Life in Patients With Esophageal and Gastric Cancer Treated With Chemotherapy

Patients with esophageal cancer and gastric cancer undergoing chemotherapy were selected as research objects to conduct nutritional risk screening, malnutrition assessment and quality of life assessment. They were randomized into the nutrition counseling group (NC) and the nutrition support therapy group (NST). To evaluate the nutrition and life quality of patients with esophageal cancer and gastric cancer before and after chemotherapy, and to study the effects of nutritional support therapy on nutrition and life quality.

Study Overview

• Status: Not yet recruiting
• Conditions: Nutrition Aspect of Cancer
• Intervention / Treatment: Dietary supplement: Nutritional counseling，Enteral Nutrition

Detailed Description

In view of the high incidence of malnutrition in esophageal cancer and gastric cancer and chemotherapy may further aggravate malnutrition and reduce quality of life. According to the inclusion criteria, 280 patients with esophageal cancer and gastric cancer undergoing chemotherapy were selected as research objects to conduct nutritional risk screening, malnutrition assessment and quality of life assessment. They were randomized into the nutrition counseling group (NC) and the nutrition support therapy group (NST). To evaluate the nutrition and life quality of patients with esophageal cancer and gastric cancer before and after chemotherapy, and to study the effects of nutritional support therapy on nutrition and life quality; On this basis, a nutrition and life quality management system for patients with tubular upper digestive tract chemotherapy tumors was constructed, and the system was objectively evaluated from the clinical point of view, so as to provide a feasible scheme for improving the nutrition and life quality of patients with tubular upper digestive tract chemotherapy tumors.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Esophageal or gastric cancer confirmed by histology or cytology;
• Age 18-75 years old, gender unlimited;
• Blood routine: hemoglobin ≥90g/L, absolute neutrophil count (ANC) ≥1.5×109/L, platelets ≥100×109/L; (2) Liver and kidney function: alanine transaminase（ALT）, glutamic-oxalacetic transaminease（AST）≤2.5 times the normal upper limit (with liver metastasis ≤5 times the normal upper limit); ALP≤2.5 times the normal upper limit (≤5 times the normal upper limit for patients with liver or bone metastasis); Serum total bilirubin (TBIL) was less than 1.5 times the normal upper limit. Serum creatinine (SCr) < 1.5 times the upper limit of normal; ③ Blood biochemistry: Serum albumin (ALB) ≥30g/L;
• Predicted survival of more than 3 months; It is planned to continue chemotherapy for >3 cycles in the hospital or outpatient department
• All patients participated in this study voluntarily and signed informed consent.

Exclusion Criteria:

• Other tumors, including pancreatic cancer, liver cancer and other solid digestive tract tumors, colon cancer, rectal cancer and other tubular lower digestive tract tumors;
• Have serious heart, lung and brain diseases; Complicated with chronic hepatitis, cirrhosis, chronic nephritis, renal insufficiency, etc.
• Fever associated with infection; Have difficult-to-control diabetes or other metabolic diseases;
• Patients with unstable vital signs and multiple organ failure;
• The patient has poor cognitive ability and is unable to answer questions or fill out questionnaires.
• The investigator believes that the subjects have a history of other serious systemic diseases or are not suitable for participating in this clinical study for other reasons

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Nutritional Counseling
Experimental: Nutrition Support Therapy	Dietary supplement: Nutritional counseling，Enteral Nutrition; patients with esophageal cancer and gastric cancer undergoing chemotherapy were selected as the study objects for nutritional risk screening, malnutrition assessment and quality of life assessment. Randomly enter the nutrition consultation group (NC) and nutrition support treatment group (NST)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional risk screening（NRS） 2002 scale	Nutritional risk screening（NRS） 2002 scale of patients with esophageal and gastric cancer before and after chemotherapy. The score includes 0,1,2,3,4,5,6 and 7.	Nutritional risk screening（NRS） 2002 scale during day 1 and day 42

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rates of malnutrition of patients	Rates of malnutrition of patients with esophageal and gastric cancer before and after chemotherapy. The result is shown as "percent".	rates of malnutrition of patients during day 1 and day 42
quality of life of patients with esophageal and gastric cancer before and after chemotherapy	quality of life of patients with esophageal and gastric cancer before and after chemotherapy. The scale include EQ-5D (score of 0-1）	rates of quality of life of patients during day 1 and day 42
quality of life of patients with esophageal and gastric cancer before and after chemotherapy	quality of life of patients with esophageal and gastric cancer before and after chemotherapy. The scale include EQ-5D VAS (score of 1-100）	rates of quality of life of patients during day 1 and day 42

Collaborators and Investigators

• Sponsor: Hunan Cancer Hospital
• Collaborators: The Third Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Estimated): August 30, 2023
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: July 11, 2023
• First Submitted That Met QC Criteria: August 31, 2023
• First Posted (Actual): September 5, 2023

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: HunanCH-50

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No