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

NCT06022770 | Unknown

• 1 other identifier: HunanCH-50
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nutrition Aspect of Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• rates of malnutrition of patients

  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

  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

  rates of quality of life of patients during day 1 and day 42

Study Arms (2)

Nutritional Counseling

NO INTERVENTION

Nutrition Support Therapy

EXPERIMENTAL

Dietary Supplement: Nutritional counseling，Enteral Nutrition

Interventions

Nutritional counseling，Enteral Nutrition 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)

Nutrition Support Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hunan Cancer Hospital: lead
• The Third Xiangya Hospital of Central South University: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: September 5, 2023
• Study Start: August 30, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: September 5, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share