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

July 23, 2021 updated by: Stanislaw Klek, Stanley Dudrick's Memorial Hospital

Preoperative Use of the High Protein ONS vs Immunoenhancing ONS in Gastrointestinal Cancer Patients Undergoing Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

299

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Skawina, Poland, 32-050
        • Stanley Dudrick's Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • resectable GI cancer
  • written consent

Exclusion Criteria:

  • inoperable GI cancer
  • known allergy to the drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High Protein
Provision of 400 ml per day of high protein oral nutritional supplements
Drug: resource protein
Administration of oral high-protein oral supplement
Experimental: Immuno ONS
Provision of 400 ml per day of immunostimulating oral nutritional supplements
Drug: IMPACT
Administration of oral immunostimulating oral supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infectious complications
Time Frame: 6 months
Number and type of infectious complications
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical complications
Time Frame: 6 months
Number and type of surgical complications
6 months
Length of stay
Time Frame: 14 days
Hospital length of stay
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanley Dudrick's Memorial Hospital

Investigators

  • Study Director: Stanislaw Klek, Stanley Dudrick's Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

March 31, 2021

Study Registration Dates

First Submitted

June 5, 2019

First Submitted That Met QC Criteria

June 7, 2019

First Posted (Actual)

June 10, 2019

Study Record Updates

Last Update Posted (Actual)

July 26, 2021

Last Update Submitted That Met QC Criteria

July 23, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Imm1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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