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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Impact Oral | Experimental | Preoperatively: 1 bottle each time (250ml/bottle), 3 times per day, equivalent to approximately 1060.5kcal per day. Postoperatively:
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| Enteral nutrition Emulsion(TPF-T) | Active Comparator | Preoperatively: 272ml each time, 3 times per day, equivalent to approximately 1060.5kcal per day. Postoperatively:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Impact Oral | Other | Impact Oral belongs to Food for Special Medical Purpose (FSMP) according to China registration regulation, including Omega-3 fatty acids, Arginine and Nucleotides immunonutrition. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianchun Yu, MD | Peiking Union Medical College Hospital | Principal Investigator |
| Gang Xiao, MD | Beijing Hospital | Principal Investigator |
| Yingjiang Ye, MD | Peiking University People's Hospital | Principal Investigator |
| Baogui Wang, MD | Tianjin Tumor Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peiking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| Enteral Nutrition Emulsion(TPF-T) | Other | TPF-T |
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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 |
| D005767 |
| Gastrointestinal Diseases |