MedTrace Logo

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

NCT05606848 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2024-07-01

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Fresenius Kabi Sino-Swed Pharmaceutical Corp. Ltd

    lead INDUSTRY

Principal Investigators

  • Hanping Shi, MD · Capital Medical University Affiliated Beijing Shijitan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-30
Primary Completion
2025-03-31
Completion
2025-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05606848 on ClinicalTrials.gov