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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
308
Impact Oral belongs to Food for Special Medical Purpose (FSMP) according to China registration regulation, including Omega-3 fatty acids, Arginine and Nucleotides immunonutrition.
TPF-T
Peiking Union Medical College Hospital
Beijing, Beijing Municipality, China
Change of Serum Prealbumin level
The change of serum prealbumin level on Day 8 after surgery compared with baseline (before study products treatment).
Time frame: Change measures at baseline and Day 8 after surgery
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: Change measures at baseline, Day -1(before surgery), Day1, 3, 8(after surgery)
Incidence of postoperative Infections
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Incidence of postoperative infections up to Day 8 after surgery
Time frame: up to Day 8 after surgery