Gastric cancer
Conditions
Interventions
Intervention group:Individualized nutritional support therapy and follow-up by a clinical pharmacist using enteral nutrition containing water-soluble dietary fiber.
(1) Patients with no preoperative n
from the 2nd postoperative day, 500 ml of whole nutrient formula for special medical use (Jialichang) should be infused orally/transnasally by infusion pump at the rate of 20~30 ml/h
from the 3rd postoperative day, 1,000~1,500 ml of Jialichang should be infused orally/transnasally by infusion pump at the rate of 40~60 ml/h. Infusion of 1000~1500 ml of gallethan by infusion pump at
Sponsors
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1)Agreed to participate in this study and signed the informed consent form (ICF); (2) aged 18-75 years; (3) patients with gastric cancer diagnosed by histology or imaging and undergoing elective radical surgery; (4) had not received radiotherapy and/or chemotherapy in the 1 month prior to enrollment; (5) hemoglobin>=90 g/L; (6) albumin >=30 g/L; (7) body mass index (Body Nass Index (BMI)) 16-28 kg/m^2; (8) preoperative Eastern Cooperative Oncology Group (ECOG) physical status score of 0-2; and (9) ability to communicate well with the investigator and comply with the entire trial requirements.
Exclusion criteria
Exclusion criteria: Exclusion criteria: (1) nutritional assessment of malignancy; (2) presence of contraindications to enteral nutrition (EN) or EN intolerance, such as acute gastrointestinal bleeding, intestinal obstruction (>= grade 3, National Cancer Institute-Common Terminology Criteria for Adverse Events [NCINCI-CTCAE v 5.0]), etc.; (3) known refractory metabolic disease (e.g., poorly controlled diabetes mellitus or fasting glucose >=10 mmol/L, hyperthyroidism, hypothyroidism, metabolic acidosis); (4) any inborn defects in amino acid or carbohydrate metabolism, such as phenylalaninemia, galactosemia; (5) conditions other than cancer and surgery that may be associated with weight loss, such as severe active clinical infections (> grade 2, NCI-CTCAE 5.0), including active tuberculosis, the self-reported HIV infection or active hepatitis B or C; (6) cardiac insufficiency (New York Heart Association Cardiac Function Classification NYHAF > Class III); (7) severe hepatic insufficiency (significant elevation of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times the upper limit of the normal range [ULN] or total bilirubin > 3 times the ULN); (8) Severe renal insufficiency (serum creatinine concentration > 1.5 times ULN and/or need for dialysis); (9) refractory bleeding undergoing treatment; (10) other malignancies diagnosed within the past 3 years (except for eradicated basal cell carcinoma of the skin, and cervical carcinoma in situ); (11) known medical conditions that may significantly interfere with the digestion and absorption of the study product; (12) history of drug addiction within the 6 months prior to screening or a history of alcohol abuse; (13) taking drugs that promote muscle growth (e.g., anabolic agents, etc.) at the time of screening; (14) known allergy to ingredients of the test product or the control product; (15) pregnancy or breastfeeding; (16) participation (or plan to participate) in another clinical trial of an investigational drug product, FSMP, or medical device within 1 month prior to the start of this study, or during the study period; (17) inability to understand the verbal and written information, or unwillingness or inability to comply with scheduled visits and study protocol requirements; and (18) other circumstances that, in the opinion of the investigator, make participation in the study inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prealbumin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to tolerate enteral nutrition;Time to reach 60% of target volume;Laboratory indices (albumin, hemoglobin, total protein, C-reactive protein, IL-6, TNF-a, neutrophil/lymphocyte ratio);Economic indicators (hospitalization costs, drug costs, anti-infective drug costs);Postoperative recovery indicators (time to fluid tolerance, time to first gas and bowel movement, length of postoperative hospitalization, length of parenteral nutrition use);Serum amino acids;Urine gut microbial metabolites short-chain fatty acids (acetic, propionic, butyric, isobutyric, valeric, isovaleric, hexanoic, heptanoic, lactic); | — |
Countries
China
Contacts
Public ContactXiaojie Bian
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Outcome results
None listed