NCT05301556

Food for Special Medical Purpose in Patients With Digestive Tract Tumor

Effect of a Food for Special Medical Purpose (FSMP) Product During the Perioperative Period in Patients With Digestive Tract Tumor

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 326 (actual)
• Sponsor: Abbott Nutrition · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Gastrointestinal Cancer

Interventions

Type	Name	Description
OTHER	Experimental Product	* 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
OTHER	Control Product	* 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

Timeline

• Start date: 2022-06-24
• Primary completion: 2024-01-09
• Completion: 2024-01-09
• First posted: 2022-03-29
• Last updated: 2024-03-01

Locations

8 sites across 1 country: China