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

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04732442
• Other study ID #: JagiellonianU-07
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: January 30, 2019

Study information

• Verified date: January 2021
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 30, 2019
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms
• Nutrition Aspect of Cancer

Intervention

Dietary Supplement:
• Immunonutrition
Impact Oral® Nestle, Switzerland
• Standard Oral Nutritional Support
Fortimel Compact Protein® Nutricia, United Kingdom

Locations

Country	Name	City	State
Poland	2nd Department of General Surgery, Jagiellonian University Medical College	Kraków	Malopolska

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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-a), 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	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