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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colon Cancer, Nutrition Aspect of Cancer

Intervention / Treatment
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* Dietary Supplement: Immunonutrition
* Dietary Supplement: Standard Oral Nutritional Support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized 2-arm controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immuno-group<br>The immuno-group will consist of patients who, as part of preoperative nutritional support, used immunonutrition ONS (2x Impact Oral® Nestle, Switzerland per day) for 2 weeks before surgery. | Dietary Supplement: Immunonutrition<br>* Impact Oral® Nestle, Switzerland<br>* Other names: Immunonutrition Oral Nutritional Support;|
| Sham Comparator: Control-group<br>The control group will consist of patients who, as part of preoperative nutritional support, used standard ONS (3x Fortimel Compact Protein® Nutricia, United Kingdom per day) for 2 weeks before surgery. | Dietary Supplement: Standard Oral Nutritional Support<br>* Fortimel Compact Protein® Nutricia, United Kingdom<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 13 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 13 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immunonutrition, colon cancer, inflammatory response, perioperative care, randomized controlled trial