NCT05606848

To Test the Food for Special Medical Purpose in Perioperative Patients With Gastrointestinal Cancer

Efficacy and Safety of Fresubin Support Drink for Enteral Nutrition Support in Perioperative Patients With Gastrointestinal Cancer: A Prospective, Randomized, Open-Label, Active-Controlled Multi-Center Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Fresenius Kabi Sino-Swed Pharmaceutical Corp. Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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) . Not exceed 350 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.

Conditions

• Gastrointestinal Cancer

Interventions

Type	Name	Description
OTHER	Nutrition Emulsion (TPF-T)	All patients will be randomized to receive the FSMP or control product. * Before the surgery: Patients daily intake control product with recommended energy. * 1-8 days after surgery: Patients gradually increase control product intake to reach the recommended energy.
OTHER	Foods for special medical purposes [FSMP] for patients with tumors	All patients will be randomized to receive the FSMP or control product. * Before the surgery: Patients daily intake FSMP with recommended energy. * 1-8 days after surgery: Patients gradually increase FSMP intake to reach the recommended energy.

Timeline

• Start date: 2022-11-30
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2022-11-07
• Last updated: 2024-07-01

Locations

14 sites across 1 country: China