This is a prospective, randomized, controlled, unblinded, parallel, multicenter, and non-inferiority study to demonstrate the safety and efficacy of a Food for Special Medical Purpose product (FSMP) in participants with digestive tract tumor undergoing surgical resection during the perioperative period.
This is a prospective, randomized, controlled, unblinded, parallel, and multicenter, and non-inferiority study to demonstrate the safety and efficacy of a FSMP in participants with digestive tract tumor undergoing surgical resection during the perioperative period. Half of the participants will receive FSMP, the other half will receive Enteral Nutrition Emulsion (TPF-T) as an active control. Prealbumin, albumin, C-reactive protein (CRP), immunology parameters, vital signs, nutrition and safety-related laboratory parameters, compliance, and Adverse Events (AEs) will be evaluated in this study, to demonstrate its parity with TPF-T on efficacy and safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
326
* Before the surgery: FSMP provides daily target energy needed by participants * 1-2 days after surgery: Start FSMP and advance as tolerated to achieve 20% of the daily target energy needed by participants * 3rd-5th day after surgery: Gradually increase FSMP intake every day as tolerated to provide 30-80% of the daily target energy needed by participants * 6th to 11th day after surgery. FSMP provides daily target energy needed by participants
* Before surgery: TPF-T provides daily target energy needed by participants * 1-2 days after surgery: Start TPF-T and advance as tolerated to achieve 20% of the daily target energy needed by participants * 3rd-5th day after surgery: Gradually increase TPF-T intake every day as tolerated to provide 30-80% of the daily target energy needed by participants * 6th to 11th day after surgery. TPF-T provides daily target energy needed by participants
Beijing Hospital
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Peking University People's Hospital
Beijing, China
Serum Pre-Albumin
Change in pre-albumin
Time frame: Baseline to Post Op Day (POD) 9
Serum Albumin
Change in albumin
Time frame: Baseline to Post Op Day (POD) 9
Weight
Change in weight
Time frame: Baseline to Post Op Day (POD) 9
Nutritional Risk Screening (NRS) 2002
NRS-2002 scored from 0 Low Risk to 7 High Risk
Time frame: Baseline to Post Op Day (POD) 9
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Beijing Cancer Hospital
Beijing, China
Beijing Tsinghua Changgung Hospital
Beijing, China
The Six Afffilated Hospital Sun Yat-sen University
Guangzhou, China
The Affiliated Hospital of Qingdao University
Qingdao, China