Preoperative High Protein vs Immunodiet in Surgical Cancer Patients

Phase 4

Completed

• Conditions: General Surgery; Cancer of Colon
• Interventions: Drug: resource protein; Drug: IMPACT

• Registration Number: NCT03980704
• Lead Sponsor: Stanley Dudrick's Memorial Hospital

Brief Summary

Immunomodulating nutrition is supposed to reduce the number of complications and the legnth of the hospital stay during the postoperative period in patients after major gastrointestinal surgery. The aim of the study is to assess the clinical effect of immunomodulating oral nutrition in patients undergoing resection for gastrointestinal cancer in the group of well-nourished patients.

Detailed Description

Between March 1, 2019, and December 31, 2020, a group of 300 well-nourished patients will be enrolled to the study and randomly assigned two one of two groups: A-high protein oral supplements (ONS) and B- immunomodulating ONS. The study is designed to test the hypothesis that immunonutrition and reduce the incidence of infectious complications after upper gastrointestinal surgery; the secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and hospital stay.

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2019-06-05
• Study First Submitted QC: 2019-06-07
• Study First Posted: 2019-06-10
• Primary Completion: 2020-12-31
• Study Completion: 2021-03-31
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-23
• Last Update Posted: 2021-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 299

Inclusion Criteria

• resectable GI cancer
• written consent

Exclusion Criteria

• inoperable GI cancer
• known allergy to the drug

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Protein	resource protein	Provision of 400 ml per day of high protein oral nutritional supplements
Immuno ONS	IMPACT	Provision of 400 ml per day of immunostimulating oral nutritional supplements

Primary Outcome Measures

Name	Time	Method
Infectious complications	6 months	Number and type of infectious complications

Secondary Outcome Measures

Name	Time	Method
Surgical complications	6 months	Number and type of surgical complications
Length of stay	14 days	Hospital length of stay

Trial Locations

Locations (1)

Stanley Dudrick's Memorial Hospital; 🇵🇱 Skawina, Poland