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

NCT04732442 | Completed

• 1 other identifier: JagiellonianU-07
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer; Nutrition Aspect of Cancer

Keywords

immunonutrition; colon cancer; inflammatory response; perioperative care; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  up to 13 months

Study Arms (2)

Immuno-group

EXPERIMENTAL

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

Control-group

SHAM COMPARATOR

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

Interventions

Immunonutrition DIETARY_SUPPLEMENT

Impact Oral® Nestle, Switzerland

Also known as: Immunonutrition Oral Nutritional Support

Immuno-group

Standard Oral Nutritional Support DIETARY_SUPPLEMENT

Fortimel Compact Protein® Nutricia, United Kingdom

Control-group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

2nd Department of General Surgery, Jagiellonian University Medical College

Krakow, Małopolska, 30-688, Poland

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Immunonutrition Diet

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Michał Pędziwiatr, Prof.

  Jagiellonian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof., MD, PhD

Model Details: Randomized 2-arm controlled trial

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: February 1, 2021
• Study Start: November 1, 2017
• Primary Completion: November 30, 2018
• Study Completion: January 30, 2019
• Last Updated: February 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)