Preoperative High Protein vs Immunodiet in Surgical Cancer Patients

NCT ID: NCT03980704

Last Updated: 2021-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

299 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2021-03-31

Brief Summary

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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

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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.

Conditions

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General Surgery Cancer of Colon

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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High Protein

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

Group Type ACTIVE_COMPARATOR

resource protein

Intervention Type DRUG

Administration of oral high-protein oral supplement

Immuno ONS

Provision of 400 ml per day of immunostimulating oral nutritional supplements

Group Type EXPERIMENTAL

IMPACT

Intervention Type DRUG

Administration of oral immunostimulating oral supplement

Interventions

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IMPACT

Administration of oral immunostimulating oral supplement

Intervention Type DRUG

resource protein

Administration of oral high-protein oral supplement

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* resectable GI cancer
* written consent

Exclusion Criteria

* inoperable GI cancer
* known allergy to the drug
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanley Dudrick's Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Stanislaw Klek

Head of the Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stanislaw Klek

Role: STUDY_DIRECTOR

Stanley Dudrick's Memorial Hospital

Locations

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Stanley Dudrick's Memorial Hospital

Skawina, , Poland

Site Status

Countries

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Poland

Other Identifiers

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Imm1

Identifier Type: -

Identifier Source: org_study_id

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