Post-operative patients with malignant tumors (head and neck tumors, esophageal cancer)
Conditions
Interventions
Sponsors
Cancer Hospital Chinese Academy of Medical Scienc
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age 18-80 years, gender and ethnicity; 2.Patients with histological or cytological diagnosis of malignancy (including head and neck tumors, esophageal cancer) and planned surgery; 3.Patients requiring nutrition therapy according to the investigator’s judgment; 4.Expected survival of =6 months as assessed by the investigator; 5.Tolerance to enteral nutrition; 6.Participants (including male participants) have practiced effective contraception within 14 days prior to screening, agree to be free of fertility plans and voluntarily use effective contraception within 6 months from the signing of informed consent to the last nutritional treatment; 7.Be willing to agree and sign the informed consent form, and be able to comply with the visits, treatment plans, experimental examinations and other requirements of the study as specified in the schedule.
Exclusion criteria
Exclusion criteria: 1.Known history of hypersensitivity to any component of the test sample; 2.Previous treatment history of other digestive tract diseases that, in the opinion of the investigator, may affect the absorption of nutrients; 3.Presence of contraindication to enteral nutrition, and the above symptoms cannot be corrected by the investigator; 4.Any congenital deficiency of amino acid or carbohydrate metabolism, such as phenylalanineemia, galactosemia, or inborn disorder of metabolism of substances contained in the test sample; 5.Poorly controlled metabolic disease (stable for at least 3 months if previous history of thyroid disease); 6.Poorly controlled immune system diseases or uncontrolled psychological diseases; 7.History of severe cardiovascular disease: severe cardiac rhythm or conduction abnormalities; congestive heart failure and myocardial infarction with NYHA class II or above within 6 months before the first treatment; 8.Other malignancy within the past 2 years [other than adequately treated basal cell carcinoma or squamous cell carcinoma, or adequately treated non-melanoma skin cancer or malignant macula without evidence of disease, or cancer in situ that has been cured, or localized prostate cancer after radical surgery and does not require other treatment; 9.Severe active clinical infection, including active tuberculosis, or HIV infection or active syphilis infection or active hepatitis B or C; 10.Patients with hepatic and renal insufficiency or requiring dialysis; 11.Hemoglobin 1.5 × ULN; 12.Use other nutritional preparations that may affect the effect of the test within 1 day before operation; 13.Chemoradiotherapy or immunotherapy within 2 weeks prior to screening, and planned chemotherapy, radiotherapy or immunotherapy during the trial; 14.Use of drugs/substances that can significantly regulate appetite, metabolism, or body weight within 2 weeks prior to enrollment: 15.Transfusion of plasma, amino acids, albumin within 1 week before screening; 16.Have participated in any interventional clinical trial and received treatment within 4 weeks before screening, including all trials related to drugs, devices and nutritional support; 17.Lactose intolerance or intolerance to tube feeding; 18.Women who are breastfeeding, pregnant or planning to become pregnant or have a positive pregnancy test; 19.In the opinion of the Investigator, it is not appropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pre-albumin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight/BMI;Albumin;Patient-generated subjective global assessment, PG-SGA;C-reactive protein;Neutrophil to lymphocyte ratio, NLR;Blood glucose;Triglyceride;Grip;Quality of life;Performance Status Score;Physical examination;Vital signs;Laboratory tests (including hematology, urinalysis, blood chemistry);12-Lead Electrocardiogram;Number of catheter-related complications (if tube feeding route);Frequency and severity of gastrointestinal symptoms such as nausea, vomiting, abdominal distension, abdominal pain, diarrhea and constipation;Adverse Event; | — |
Countries
China
Contacts
Public ContactCong Minghua
Cancer Hospital Chinese Academy of Medical Scienc
Outcome results
None listed