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

NCT ID: NCT06022770

Last Updated: 2023-09-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-30
• Study Completion Date: 2024-12-30

Brief 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.

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.

Conditions

Nutrition Aspect of Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Nutritional Counseling

Group Type: NO_INTERVENTION

No interventions assigned to this group

Nutrition Support Therapy

Group Type: EXPERIMENTAL

Nutritional counseling，Enteral Nutrition

Intervention Type: DIETARY_SUPPLEMENT

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)

Interventions

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)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role: collaborator

Hunan Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

HunanCH-50

Identifier Type: -

Identifier Source: org_study_id