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

Study Overview
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Brief Summary
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This study will evaluate the efficacy and safety of Impact Oral in Patients undergoing Surgery for Gastrointestinal Cancer, half of the participants will receive Impact Oral nutrition therapy, the other half will receive Enteral Nutrition Emulsion(TPF-T) therapy.

Detailed Description
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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.

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

Conditions
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Gastrointestinal Cancer

Intervention / Treatment
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* Other: Impact Oral
* Other: Enteral Nutrition Emulsion(TPF-T)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Impact Oral<br>Preoperatively: 1 bottle each time (250ml/bottle), 3 times per day, equivalent to approximately 1060.5kcal per day. Postoperatively: Patient should receive: 1 bottle (250 ml each) per day of test product on D 1 and D 2 post surgery, corresponding to 353.5Kcal. 2 bottles (250 ml each) per day of test product on D 3 and D 4 post surgery, corresponding to 707Kcal. 3 bottles (250 ml each) per day of test product on D 5, D 6 and D 7 post surgery, corresponding to 1060.5 kcal. At the discretion of the authorized investigator/nutritionist, the amount of study products, can be increased to meet the daily caloric goal: 1500Kcal. | Other: Impact Oral<br>* Impact Oral belongs to Food for Special Medical Purpose (FSMP) according to China registration regulation, including Omega-3 fatty acids, Arginine and Nucleotides immunonutrition.<br>Other: Enteral Nutrition Emulsion(TPF-T)<br>* TPF-T<br>* Other names: Changnei Yingyang Ruji(TPF-T);|
| Active Comparator: Enteral nutrition Emulsion(TPF-T)<br>Preoperatively: 272ml each time, 3 times per day, equivalent to approximately 1060.5kcal per day. Postoperatively: Patient should receive: 272ml of control product on D 1 and D 2 post surgery, corresponding to 353.5Kcal. 544ml of control product on D 3 and D 4 post surgery, corresponding to 707Kcal. 816ml of control product on D 5, D 6 and D 7 post surgery, corresponding to 1060.5 kcal. At the discretion of the authorized investigator/nutritionist, the amount of study products, can be increased to meet the daily caloric goal: 1500Kcal. | Other: Impact Oral<br>* Impact Oral belongs to Food for Special Medical Purpose (FSMP) according to China registration regulation, including Omega-3 fatty acids, Arginine and Nucleotides immunonutrition.<br>Other: Enteral Nutrition Emulsion(TPF-T)<br>* TPF-T<br>* Other names: Changnei Yingyang Ruji(TPF-T);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Serum Prealbumin level | The change of serum prealbumin level on Day 8 after surgery compared with baseline (before study products treatment). | Change measures at baseline and Day 8 after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Serum Prealbumin level | Prealbumin at baseline and Day -1 before the day of surgery, and Day1 and Day 3 after the day of surgery. | Change measures at baseline and Day -1(before surgery) and Day1, Day3 after surgery | 
| Change of Albumin | Albumin at baseline, Day-1 before the day of surgery, and on Day 1, 3 and 8 after the day of surgery. | Change measures at baseline, Day -1(before surgery),Day 1, 3, 8(after surgery) | 
| Change of C-reactive protein | C-reactive protein at baseline, Day -1 before the day of surgery, and on Day 1, 3,8 after the day of surgery. | Change measures at baseline, Day -1(before surgery),Day1, 3, 8(after surgery) | 
| Change of Interleukin-6 (IL-6) | Interleukin-6 (IL-6) at baseline, Day -1 before the day of surgery, and on Day1, 3 and 8 after the day of surgery | Change measures at baseline, Day -1(before surgery), Day 1, 3, 8(after surgery) | 
| Change of CD4+/CD8+ | CD4+/CD8+ at baseline, Day-1 before the day of surgery, and on Day1, 3, 8 after the day of surgery(selected sites) | Change measures at baseline, Day -1(before surgery), Day1, 3, 8(after surgery) | 
| Incidence of postoperative Infections | Incidence of postoperative infections up to Day 8 after surgery | up to Day 8 after surgery |