esophageal cancer
Conditions
Interventions
Case series:Complete enteral nutrition (Ensure 0750)
Sponsors
Department of Thoracic Surgery, Sichuan Cancer Hospital and Institute
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subject is male or female, between 18 and 75 years old (inclusive); 2. Subject has clinical or radiological diagnosis of esophageal cancer (stage I, II, III) scheduled to undergo surgical resection; 3. Subjects did not receive radiotherapy; 4. Subjects are malnourished or have malnutrition risk (PG-SGA score> = 4 points or NRS-2002> = 3 points); 5. Female subjects are not pregnant or at least six weeks postpartum and non-lactating. A pregnancy test at Screening will be required in females of childbearing potential to confirm non-pregnancy status; 6. Subject is willing to comply with the study protocol, able and willing to consume study product according to the protocol; 7. Subject has an expected life expectancy = 3 months; 8. Subject has voluntarily signed and dated the informed consent form (ICF), approved by an Institutional Review Board (IRB) / Independent Ethics Committee (IEC) prior to any participation in the study.
Exclusion criteria
Exclusion criteria: 1. Subject has contraindication to enteral nutrition (such as active gastrointestinal hemorrhage, bowel obstruction, short bowel syndrome, severe IBD unstable vital signs, dyscoagulation, metabolic disorders that in the opinion of study physician can not be corrected); 2. Subject has severe renal and liver dysfunction reflected by blood chemistries according to lab results in medical records. Blood chemistries criteria: serum creatinine > 2 times the upper limit of normal (ULN), serum alanine transaminase (ALT) and/or aspartate transaminase (AST) > 3 times the ULN, or conjugated bilirubin > 2 times the ULN; 3. Subject has cardiac insufficiency (in the opinion of study physician); 4. Subject has type I or type II diabetes (per medical history and admission diagnosis, in the opinion of study physician); 5. Subject has severe nausea, vomiting and/or uncontrolled diarrhea/steatorrhoea within the previous week (per reported history or in the opinion of study physician); 6. Subject has known dementia, brain metastases, eating disorder, history of significant neurological or psychiatric disorder, or stated undergoing psychiatric treatment for mental illness; 7. Subject has known history of allergy or intolerance to any ingredient in the investigational product; 8. Subject has been taking any nutritional supplements regularly within 1 month prior to study entry; 9. Subject is currently or has participated in any clinical trial that has not been approved by Abbott.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| seralbumin; | — |
Countries
China
Contacts
Public ContactHan yongtao,Liu guangyuan
Department of Thoracic Surgery, Sichuan Cancer Hospital and Institute
Outcome results
None listed