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

Not Applicable

Completed

• Conditions: Nutrition Aspect of Cancer; Colon Cancer
• Interventions: Dietary Supplement: Standard Oral Nutritional Support; Dietary Supplement: Immunonutrition

• Registration Number: NCT04732442
• Lead Sponsor: Jagiellonian University

Brief 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.

Study Timeline

• Study Start: 2017-11-01
• Primary Completion: 2018-11-30
• Study Completion: 2019-01-30
• Status Verified: 2021-01
• Study First Submitted: 2021-01-19
• Study First Submitted QC: 2021-01-29
• Last Update Submitted: 2021-01-29
• Study First Posted: 2021-02-01
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control-group	Standard Oral Nutritional Support	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.
Immuno-group	Immunonutrition	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.

Primary Outcome Measures

Name	Time	Method
Change in expression of inflammatory cytokines in tumor tissue samples obtained prior and after intervention.	up to 13 months	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.

Secondary Outcome Measures

Name	Time	Method
Changes in tissue neutrophil infiltration after preoperative nutritional intervention in tumor tissue samples obtained prior and after intervention.	up to 13 months	Neutrophil infiltration will be assessed by counting the number of neutrophils per 10 large microscopic fields.

Trial Locations

Locations (1)

2nd Department of General Surgery, Jagiellonian University Medical College; 🇵🇱 Kraków, Małopolska, Poland