Malignant tumor
Conditions
Interventions
Experimental group:On the first day of radiotherapy, the subjects were provided with full nutritional support using ARG Tumor Total Nutrition Formula Powder, with the target dose being 25-30 kcal/kg/d
Control group:On the first day of radiotherapy, the subjects were provided with full nutritional support using Ruineng Enteral Nutritional Emulsion (TPF-T), with the target dose being 25-30 kcal/kg/d
Sponsors
Shanghai Ninth People’s Hosptital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged from 18 to 75 years; 2. Malignant tumor was confirmed by histopathology or cytology, and radiotherapy or chemotherapy was proposed; 3. PG-SGA >= 4 points; 4. The expected survival time was more than 12 weeks; 5. They did not participate in the intervention clinical trials of other nutrition products, drugs or devices within 4 weeks before screening; 6. Voluntary consent and informed consent.
Exclusion criteria
Exclusion criteria: 1. Diseases that seriously affect digestion and absorption of test samples or lead to intolerance of enteral nutrition (including but not limited to inflammatory bowel disease, complete intestinal obstruction, short bowel syndrome, gastrointestinal dysfunction, severe indigestion or malabsorption, etc.); 2. Severe hepatic insufficiency: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 ULN, and serum total bilirubin (TBIL) > 2 ULN,; 3. Severe renal insufficiency: creatinine clearance rate (CCR) < 30ml / min (calculated by Cockcroft / Gault formula), female CCR = [(140 years old) x body weight (kg) x 0.85] / [72 x serum creatinine (mg / dl)], male CCR = [(140 years old) x body weight (kg) x 1.00] / [72 x serum creatinine (mg / dl)]; 4. Plan to use other nutritional preparations that may affect the test effect during the trial; 5. Allergy to test product or control product ingredients; 6. Women of childbearing age had positive blood pregnancy results or were in lactation period; 7. The researcher thinks it is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| prealbumin; | — |
Secondary
| Measure | Time frame |
|---|---|
| vital signs;routine blood test;urinalysis;liver function;renal function;bloodglucose;blood lipids;electrolyte;electrocardiogram;weight;serum albumin;hemoglobin;Patient-Generated Subjective Global Assessment;grip strength of left and right hands;C-neactveprotein;neutrophil–lymphocyte ratio (NLR) ;serum total cholesterol; triglyceride;low-density lipoprotein-cholesterol;high-density lipoprotein cholesterol;EORTC QLQ-C30;gastrointestinal malfunction;catheter related complications; | — |
Countries
China
Contacts
Public ContactGuopei Zhu
Shanghai Ninth People’s Hosptital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed