Cancer population with nutritional risk or malnutrition
Conditions
Interventions
Experimental group:feeding Kangdasu
control group:feeding Ruineng
Sponsors
Beijing Shijitan Hospital.CMU
Wenzhou Medical University Affiliated First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Colorectal cancer patients confirmed by histopathological methods and planned to receive postoperative adjuvant chemotherapy (chemotherapy regimen is CAPEOX or mFOLFOX6); (2) Patients diagnosed by researchers as having malnutrition or nutritional risk (NRS2002 score = 3 in nutritional risk screening); (3) 18-85 years old, including boundary values; (4) BMI 18.5-28 kg/m2, including boundary values; (5) Estimated current savings of = 3 months; (6) Patients who can tolerate enteral nutrition; (7) Hemoglobin = 90 g/L; (8) Albumin = 2.5 g/dL; (9) ECOG physical status score is 0-2 points; (10) Voluntarily agree and sign the Informed Consent Form (ICF).
Exclusion criteria
Exclusion criteria: (1) There are contraindications for enteral nutrition (such as active gastrointestinal bleeding, intestinal obstruction, decompensated short bowel syndrome, high flow intestinal fistula, severe intraperitoneal infection, severe gastrointestinal emptying disorders, unstable vital signs, abnormal coagulation function, severe nausea, vomiting, and/or uncontrolled diarrhea/steatosis), and the researchers believe that the above symptoms cannot be corrected; (2) Previous history of treatment for other gastrointestinal diseases, and researchers have determined that it may affect nutrient absorption; (3) Suffering from other malignant tumors in the past 2 years, except for fully treated basal cell carcinoma or squamous cell carcinoma, or fully treated non melanoma skin cancer or malignant macula with no signs of disease, or cured carcinoma in situ (such as cervical carcinoma in situ, bladder carcinoma in situ, breast carcinoma in situ, etc.), or local prostate cancer after radical surgery that does not require other treatment (except hormone therapy); (4) The patient has participated in other intervention clinical trials, including clinical trials related to nutritional support, within the 4 weeks prior to enrollment; (5) The subjects received plasma, amino acids, and albumin infusions within one week prior to screening; (6) Patients with liver and kidney dysfunction [alanine aminotransferase (ALT) = 2 x upper limit of normal (ULN); serum total bilirubin (TBIL) = 2 x ULN; creatinine (Cr) = 2 x ULN]; (7) Fasting blood glucose = 10 mmol/L; (8) Patients with hyperthyroidism or hypothyroidism who have received stable medication doses for less than 3 months; (9) Within 2 weeks prior to subject screening or currently using drugs/substances that can significantly regulate appetite, metabolism, weight, or immune function: a) Appetite enhancers, pregnancy promoters, steroids (excluding nasal, topical, and ophthalmic steroids; dexamethasone used for pre-treatment of anti-tumor drugs or antiemetics is acceptable); b) Nutritional supplements/drugs containing anti-inflammatory fat emulsions, Omega 3 fatty acids, proteins, glutamine or arginine (excluding multivitamins and multiple mineral supplements); c) Drugs/substances that can significantly regulate immune function, including but not limited to thymosin, biologics (such as anti-tumor necrosis factor), and immunotherapy; (10) New York Heart Association (NYHA) functional class III or higher; (11) Pregnant, lactating female patients, or women with fertility who test positive for baseline pregnancy tests; (12) Known history of allergies to any ingredients of the research product; (13) Uncontrolled psychological disorders; (14) Need to accept supporters of parenteral nutrition; (15) Those who are bedridden and unable to measure their weight; (16) Other researchers believe that participants should not participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum prealbumin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital signs, physical examination, laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function test), 12-ECG, gastrointestinal reactions, AE and SAE;Body weight and BMI, serum albumin, hemoglobin, PG-SGA;grip,CRP,NLR,Fasting blood glucose,ECOG; | — |
Countries
China
Contacts
Public ContactShi Hanping
Beijing Shijitan Hospital.CMU Wenzhou Medical University Affiliated First Hospital
Outcome results
None listed