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

Nutrition Aspect of Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06022770
• Other study ID #: HunanCH-50
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 30, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: August 2023
• Source: Hunan Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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; ? 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

Related Conditions & MeSH terms

• Nutrition Aspect of Cancer
• Stomach Neoplasms

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hunan Cancer Hospital	The Third Xiangya Hospital of Central South University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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