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

Jagiellonian University30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Colon Cancer Nutrition Aspect of Cancer

Interventions

ImmunonutritionDIETARY_SUPPLEMENT

Impact Oral® Nestle, Switzerland

Standard Oral Nutritional SupportDIETARY_SUPPLEMENT

Fortimel Compact Protein® Nutricia, United Kingdom

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in expression of inflammatory cytokines in tumor tissue samples obtained prior and after intervention.

Expression of following inflammatory cytokines will be measured: Tumor necrosis factor (TNF-α), Interleukin 8 or chemokine (C-X-C motif) ligand (CXCL8), stromal cell-derived factor 1 (SDF-1a), Chemokine (C-X-C motif) ligand 6 (CXCL6), Chemokine (C-X-C motif) ligand 2 (CXCL2), myeloperoxidase (MPO), Chemokine (C-X-C motif) ligand 1 (CXCL1) prior and after intervention. Measurements of cytokines' tissue concentration will be presented in pg/100ug of total protein.

Time frame: up to 13 months

Secondary Outcomes

Changes in tissue neutrophil infiltration after preoperative nutritional intervention in tumor tissue samples obtained prior and after intervention.

Neutrophil infiltration will be assessed by counting the number of neutrophils per 10 large microscopic fields.

Time frame: up to 13 months

Data from ClinicalTrials.gov

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