Colorectal cancer
Conditions
Interventions
Experimental Group:Zhongyuantai Foods for Special Medical Purpose (FSMP) for Tumor
Control Group:Suyisu Foods for Special Medical Purpose (FSMP) for Tumor
Sponsors
Affiliated Hospital of Jiangnan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–80 years (including the boundary values), no restrictions on gender or ethnicity; 2. Diagnosed with colorectal cancer confirmed by pathological methods; 3. Have completed laparoscopic radical surgery for colorectal cancer and require adjuvant chemotherapy after surgery, with the first chemotherapy regimen being CAPEOX (XELOX); 4. Assessed by the researcher as having nutritional risk or malnutrition and requiring nutritional intervention, with Nutritional Risk Screening (NRS-2002) score =3 or Patient-Generated Subjective Global Assessment (PG-SGA) score>=4; 5. Able to tolerate enteral nutrition; 6. Estimated survival >=3 months; 7. BMI between 16 kg/m² and <32.5 kg/m²; 8. Voluntarily participate in the clinical trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Contraindications to enteral nutrition as assessed by the investigator, including but not limited to: active gastrointestinal bleeding, intestinal obstruction, decompensated short bowel syndrome, intestinal fistula, intraperitoneal infection, gastrointestinal emptying disorders, and severe nausea and vomiting (NRS>=7 points), and the above symptoms cannot be corrected in the opinion of the investigator; 2. History of malignant tumors: Patients with new diagnoses of other active malignancies within the past 2 years (i.e., within the first 24 months at the time of screening) should be excluded. However, enrollment is allowed in the following situations if adequately treated and there are no signs of disease at present: low-risk skin malignancies (such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin); Cured carcinoma in situ (such as carcinoma in situ of the cervix, carcinoma in situ of the bladder, carcinoma in situ of the ducts of the breast, etc.); or localized prostate cancer that has undergone radical surgery without subsequent treatment (other than hormone therapy). For any other malignant tumors diagnosed before 2 years, they must have received curative treatment, have no evidence of recurrence or metastasis, and their medical history is assessed by the investigator to be considered that their medical history will not interfere with the efficacy and safety evaluation of this study; 3. Any laboratory test index meets the following criteria: abnormal renal function, serum creatinine (Cr) >=2 times the upper limit of normal value; Abnormal liver function, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >=2 times the upper limit of normal value, or total bilirubin (TBIL) >=1.5 times the upper limit of normal value; Fasting blood glucose >=10mmol/L; Hemoglobin < 90g/L; albumin < 27g/L; 4. Subjects who are expected to not be able to take the test product as prescribed and cannot take nutrition orally; 5. Previous history of treatment for other digestive tract diseases, and the investigator judged that it may affect nutrient absorption; 6. Use of other nutritional preparations that may affect the effect of the trial (such as Suyisin, Ruineng and other tumor-specific complete nutritional preparations) within 2 weeks before enrollment; 7. Known history of allergy or intolerance to any component of the investigational product; 8. Participation in other interventional clinical trials (including drugs, nutritional preparations, medical devices, etc.) within 4 weeks before enrollment; 9. Pregnant and lactating female patients or women of childbearing potential with positive pregnancy test test; 10. Within 2 weeks before enrollment or is using drugs/substances that can significantly regulate appetite, metabolism, body weight, or immune function: (1) appetite enhancers (such as amitriptyline), progesterone (such as progestogen), steroids (nasal aspiration, topical and ocular steroids are allowed); (2) Nutritional supplements/medications containing anti-inflammatory fat emulsions, Omega-3 fatty acids, proteins, glutamine, or arginine (multivitamin and multimineral supplements are allowed); (3) Continuous use of olanzapine, glucocorticoids, growth hormone, dronabinol or other anabolic drugs as antiemetic drugs for more than 2 weeks; (4) Drugs/substances that can significantly regulate immune function, such as thymosin, biological agents (such as anti-tumor necrosis factor, immunotherapy), except for the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physical Examination;Prealbumin (PAB);The Gastrointestinal Symptom Rating Scale (GSRS);Adverse Events (AE) and Serious Adverse Events (SAE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Nutritional Risk Screening (NRS-2002) Score;Body Mass Index (BMI);Vital Signs: Pulse, Respiratory Rate, Body Temperature, Blood Pressure;Urinalysis + Urinary Sediment Quantification;Immune-Related Evaluation Indicators;Hemoglobin (HGB);Blood Biochemistry;Complete Blood Count;ECOG Performance Status Score;Blood Lipids;12-Lead Electrocardiogram;C-Reactive Protein (CRP);Fasting Blood Glucose;Handgrip Strength;Patient-Generated Subjective Global Assessment (PG-SGA) Score;Body Weight;Albumin (ALB); | — |
Countries
China
Contacts
Public ContactFeng Zhang
Affiliated Hospital of Jiangnan University
Outcome results
None listed