gastric cancer
Conditions
Interventions
Immunonutrition:One bottle of Oral Impact (250ml/bottle, National Food and Drug Administration Registration No. TY20220004, Nestle Health Science (China) Co., Ltd.) three times a day, providing approx
Control:One bottle of Rui Neng (200ml/bottle, Chinese drug approval number H20040722, Pfizer (China) Pharmaceuticals Co., Ltd.) four times a day, providing approximately 1063kcal per day.
Sponsors
The Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: All patients must meet the following criteria: 1. Both genders are eligible (female subjects must not be pregnant or lactating for at least 6 weeks postpartum); 2. Subjects aged between 18 and 75 years (inclusive); 3. Subjects with histologically confirmed gastric malignant tumors and planned for surgery (laparoscopic or robotic) resection plus gastrointestinal reconstruction surgery; 4. Subjects diagnosed with cancer cachexia; 5. Subjects with an NRS-2002 score of =3 points. 6. The subject's body mass index is 18-30kg/m2; 7. No blood products were transfused within one week prior to screening; 8. Before participating in the study, the subjects voluntarily signed an informed consent form approved by the institutional review committee and indicated the date.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria at baseline visit will be excluded from the study: 1. Subjects with a life expectancy of less than 3 months; 2. Subjects with contraindications to enteral nutrition (e.g., decompensated short bowel syndrome, high-output enterocutaneous fistula, severe peritoneal infection, severe gastrointestinal obstruction, unstable vital signs, abnormal coagulation function, severe nausea, vomiting) that the investigator deems irreversible; 3. Subjects who received plasma, red blood cells, albumin, amino acids, or radiotherapy and/or chemotherapy within one week before screening; 4. Subjects with serum albumin 2x upper limit of normal); 8. Subjects with hepatic dysfunction [serum alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2x upper limit of normal or severe bile stasis (conjugated bilirubin >2x upper limit of normal)]; 9. Subjects with severe heart failure (e.g., with severe arrhythmia or atrial fibrillation; within 3 months before screening visit had an episode of myocardial ischemia or received stent surgery with unstable cardiac function); 10. Subjects who are not type I or II diabetics with a fasting blood glucose =8mmol/L; 11. Subjects with a history of significant neurological dysfunction or psychiatric disorders; 12. Subjects with a history of alcohol abuse, drug abuse, or other conditions that the investigator considers may interfere with the intake of study products or adherence to the study protocol; 13. Known allergy or intolerance to any components of the investigational product; 14. Subjects currently taking drugs/substances that significantly modulate appetite, metabolism, or inflammation levels: appetite stimulants, fertility agents, steroids (nasal, topical, and ophthalmic steroids are acceptable), anti-inflammatory lipid emulsions, or oral nutritional supplements/drugs containing omega-3 fatty acids, glutamine, or arginine; dexamethasone, growth hormone, or other metabolic affecting drugs; 15. Subjects receiving tumor immunotherapy or using drugs with significant immunomodulatory functions, such as: PD-1 or PD-L1 inhibitors; CTLA-4 inhibitors; thymosin; azathioprine; cyclosporine; tacrolimus; tumor necrosis factor antagonists; polysaccharides from Ganoderma lucidum (reishi mushroom); and Chinese herbal immune modulators; 16. Subjects with active tuberculosis or human immunodeficiency virus (HIV) infection; Subjects who participated in other clinical trials within 4 weeks prior to screening will also be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Infectious complications;30-day readmission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hematological parameters;length of hospital stay(LOS);total hospitalization costs;Time to first flatus and bowel movement;duration of antibiotic use; | — |
Countries
China
Contacts
Public ContactShougen Cao
The Affiliated Hospital of Qingdao University
Outcome results
None listed