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Changes in Inflammatory Response After Immunonutrition Compared to Standard Nutrition in Colorectal Cancer Tissue

Changes in Inflammatory Response After Immunonutrition Compared to Standard Nutritional Support in Colorectal Cancer Tissue - Randomized Controlled Trial

NCT04732442•Jagiellonian University

View on ClinicalTrials.gov

Summary

It is Randomized Controlled Trial, in which investigators will estimate the impact of the use of immunonutrition support compared to standard nutritional support in the preoperative period in patients with colorectal cancer.

Detailed Description

The first choice of treatment in colorectal cancer is surgery. Nutritional support in form of oral nutritional supplements (ONS) in the preoperative period is widely accepted in reducing the incidence of perioperative complications and immunonutrition is generally recommended. However, there is little clinical data regarding the impact of such treatment on a tumor biology. Investigators want to perform Randomized Controlled Trial to explore the impact of the use of immunonutrition in relation to standard nutritional support in the preoperative period on alternating the expression of inflammatory response cytokines expression and leukocytes infiltration in tumor tissue in patients operated for colorectal cancer.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of colon cancer during preoperative colonoscopy confirmed by histopathological examination.

Exclusion Criteria

•emergency/urgent operation
•active infection
•inflammatory bowel diseases in history
•other systemic immune disorders
•the necessity of preoperative neoadjuvant treatment (radiotherapy or chemotherapy)
•metastatic disease, or local infiltration of cancer which was described as T4 stage in preoperative CT scan
•patients who were not able to intake at least 85% of administrated ONS doses

Locations (1)

2nd Department of General Surgery, Jagiellonian University Medical College

Krakow, Małopolska, Poland

Key Dates

Start Date

November 1, 2017

Primary Completion Date

November 30, 2018

Completion Date

January 30, 2019

Last Updated

February 1, 2021

Enrollment

ACTUAL participants

Conditions

Colon CancerNutrition Aspect of Cancer

Interventions

Immunonutrition

DIETARY_SUPPLEMENT

Standard Oral Nutritional Support

DIETARY_SUPPLEMENT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 1, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Changes in Inflammatory Response After Immunonutrition Compared to Standard Nutrition in Colorectal Cancer Tissue

Inclusion Criteria

Exclusion Criteria

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