Preoperative High Protein vs Immunodiet in Surgical Cancer Patients (Preop immuno)

Stanley Dudrick's Memorial Hospital

Status and phase: Completed; Phase 4

Conditions: Cancer of Colon; General Surgery

Treatments: Drug: IMPACT; Drug: resource protein

Study type: Interventional

Funder types: Other

Identifiers

NCT03980704

Imm1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 299 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• resectable GI cancer
• written consent

Exclusion criteria

• inoperable GI cancer
• known allergy to the drug

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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299 participants in 2 patient groups

High Protein

Active Comparator group

Description:

Provision of 400 ml per day of high protein oral nutritional supplements

Treatment:

Drug: resource protein

Immuno ONS

Experimental group

Description:

Provision of 400 ml per day of immunostimulating oral nutritional supplements

Treatment:

Drug: IMPACT