Effects of Immunonutrition (Impact Oral®) in Patients Undergoing Surgery for Gastrointestinal Cancer

The present protocol describes a randomized, active-controlled, open labelled study in which either IMPACT Oral or Enteral Nutrition Emulsion(TPF-T) will be given to surgical patients for 5 days before surgery and 7 days after surgery. Both of the study products include immunonutrition, but the nutrient proportion is different.

Prealbumin, C-reaction protein (CRP), Albumin，immunology parameters, the results of physical examination, vital signs, relevant nutrition- and safety-related laboratory parameters and the number, severity, seriousness, relatedness and outcome of Adverse Events (AEs) will be evaluated in this study.

Inclusion criteria

• Patients with upper or lower gastrointestinal cancer confirmed by histological method and scheduled for radical resection via open or laparoscopic surgery plus gastrointestinal reconstruction. Radiotherapy and/or Chemotherapy was not performed within 2 weeks before screening.
• Age18-75 years old (include 18 and 75 years old).
• Body Mass Index 18.5-28kg/m2 (include 18.5 and28kg/m2).
• Life expectancy more than 3 months.
• Plasma haemoglobin ≥ 90g/l.
• Plasma albumin ≥2.5 g/dl.
• No blood product infused within 1 week prior to screening.
• Patients are informed for consent, and agreed to participate in the study and sign the informed consent.

Exclusion criteria

• Severe concomitant clinical conditions that could jeopardize the trial performance and follow-up.
• Past history of gastrointestinal surgery or other treatment of digestive tract, and affect the nutrient absorption
• Female patient who is pregnant or lactating woman.
• Patient undergoing minor gastrointestinal cancer surgery such as confirmatory biopsy or endoscopy. Patient that has endoscopic tumour resection is also excluded.
• Patient is not allowed any oral or enteral intake in the pre-operative phase of the study.
• Having participated in another interventional clinical trial including those related to nutritional support within 4 weeks prior to the patient enrollment.
• Other malignancies in the last 5 years (except for successfully treated in situ basocellular skin and in situ cervical uterine tumours).
• Patient who is not willing and not able to comply with scheduled visits and the requirements of the study protocol.
• Planned chemotherapy, radiotherapy or immunotherapy during the first 7 days following the surgical tumour resection.
• Patient with liver and kidney dysfunction (alanine aminotransferase ALT ≥ 2 times the upper limit of normal; total bilirubin TBIL ≥ 2 times the upper limit of normal; creatinine Cr ≥ 2 times the upper limit of normal).
• Known to have diabetes or fasting blood glucose≥ 10mmol/L.
• Known to have hyperthreosis or hypothyreosis
• Patient currently treated with Omega-3 fatty acid-containing fat emulsion, glutamine, thymosin, hormone, thyroxine, growth hormone, anti-TNF biological.
• Known to have allergic history to any component of the investigational product.
• Uncontrolled psychological disease.