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NCT Number: NCT04732442

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

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.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Nutrition Aspect of Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

2nd Department of General Surgery, Jagiellonian University Medical College

Krakow, Małopolska, 30-688, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immunonutrition

Dietary Supplement

Impact Oral® Nestle, Switzerland

Other names: Immunonutrition Oral Nutritional Support

Standard Oral Nutritional Support

Dietary Supplement

Fortimel Compact Protein® Nutricia, United Kingdom

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: up to 13 months

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

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Feb 1, 2021
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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