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Clinical Trial Summary

This is a prospective, randomized, open label, active-controlled, multi-centre, non-inferiority clinical trial. Aim of the study is to evaluate the efficacy and safety of Fresubin Support Drink in patients with gastrointestinal cancer undergoing surgical resection during the perioperative period.


Clinical Trial Description

This is a prospective, randomized, open label, active-controlled, multi-centre, non-inferiority clinical trial. The IMP includes study product and control product. The study product will be Fresubin Support Drink (FSMP), the control product will be Enteral Nutrition Emulsion(TPF-T) . 250 patients will be randomly assigned to the Fresubin Support Drink (FSMP) group or Enteral Nutrition Emulsion(TPF-T) group at a ratio of 1:1. 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05606848
Study type Interventional
Source Fresenius Kabi Sino-Swed Pharmaceutical Corp. Ltd
Contact
Status Enrolling by invitation
Phase N/A
Start date November 30, 2022
Completion date February 2024

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