Patients with esophageal and esophagogastric junction cancer and head and neck cancer after surgery
Conditions
Interventions
Experimental group:Feeding Teyiquan
Control group:Feeding Ruineng TPF-T
Sponsors
Cancer Hospital Chinese Academy of Medical Scienc
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with histologically or cytologically confirmed esophageal or esophagogastric junction cancer, head and neck cancer, and planned surgery without chemoradiotherapy within 2 weeks before screening; Patients requiring nutritional therapy (NRS2002 total score >=3, PG-SGA>=4, or expected to be unable to consume 60% of the recommended energy intake for more than one week after surgery; 2. Satisfy one of them); 3. Age of 18-80 years old (including 18 years old), regardless of gender; 4. Body mass index 18.5-30 kg/m2 (including 18.5kg/m2); 5. Hemoglobin >=90g/L; 6. Serum albumin >=30g/L; 7. Expected survival time >=6 months.
Exclusion criteria
Exclusion criteria: 1. Contraindication or intolerance to enteral nutrition, such as acute gastrointestinal bleeding, intestinal obstruction (grade >=3 NCI-CTCAE 5.0); 2. Any inborn errors of amino acid or carbohydrate metabolism such as phenylalaninemia, galactosemia, or inborn errors of metabolism to substances contained in the test foods; 3. Individuals with a known history of allergy to any component of the study product; 4. The presence of medical conditions other than cancer and surgery that may be associated with weight loss, such as severe active clinical infection (grade > 2, NCI-CTCAE 5.0), including active tuberculosis, or self-reported HIV infection or active hepatitis B or C; 5. Subjects were using drugs/substances that significantly regulate appetite, metabolism, or weight within 2 weeks prior to randomization: a. Appetite enhancers, progestational agents, steroids (nasal, topical and ocular steroids are acceptable); b. nutritional supplements/medicines containing anti-inflammatory lipid emulsions, ?-3 fatty acids, proteins, glutamine or arginine, (multivitamin and multi-mineral supplements are acceptable); c. Drugs/substances that can significantly regulate immune function (thymosin, biological agents (such as anti-tumor necrosis factor)); 6. Subjects received plasma, amino acids, and albumin infusion within 1 week before screening; 7. Known refractory metabolic diseases (such as poorly controlled diabetes or fasting blood glucose >=10mmol/L, hyperthyroidism, hypothyroidism, metabolic acidosis); 8. Cardiac dysfunction (New York Heart Association functional class > III); 9. There may be known or previous diseases, surgeries or treatments that seriously affect digestion and absorption; 10. Complicated with other serious organ diseases or uncontrolled endocrine, metabolic or immune system diseases, or with ascites or edema, jaundice, fever or infection; 11. Participated in any interventional clinical trial within 4 weeks before enrollment, including all trials related to drugs, devices, and nutritional support; 12. Other malignant tumors in the past 5 years (excluding successful treatment of in situ basal cell skin and in situ cervical and uterine tumors); 13. Patients who are unwilling and unable to comply with the scheduled visit and study protocol requirements (including those who cannot take the prescribed dose as required); 14. Chemotherapy, radiotherapy, or immunotherapy was planned during the trial; 15. Moderate-to-severe hepatorenal dysfunction (alanine aminotransferase or aspartate aminotransferase = 5 times the upper limit of normal; Or total bilirubin (TBIL) >= 3 times the upper limit of normal; Or creatinine Cr>= 1.5 times upper limit of normal) or requiring dialysis; 16. Uncontrolled mental illness; 17. Women who are breastfeeding, pregnant or preparing to become pregnant; 18. Patients deemed by the investigator to be ineligible for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pre-albumin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight;Albumin;Patient-generated subjective global assessment, PG-SGA;C-reactive protein;Neutrophil to lymphocyte ratio, NLR;Grip;Blood glucose;Triglyceride;Quality of life (QLQ-C30);Adverse events and serious adverse events that occurred during the study;The catheter-related complications occurred during the study period, including nasopharyngeal mucosal injury, feeding tube blockage, and infection related to the placement of nutritional tube stoma;Vital signs: body temperature, pulse/heart rate, blood pressure;Laboratory tests: blood routine, urine routine, liver function, renal function, fasting blood glucose, blood lipid, electrolyte;12-lead ecg; | — |
Countries
China
Contacts
Public ContactCong Minghua
Cancer Hospital Chinese Academy of Medical Scienc
Outcome results
None listed