Back to results

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

Primary Purpose

Colon Cancer, Nutrition Aspect of Cancer

Status

Completed

Phase

Not Applicable

Locations

Poland

Study Type

Interventional

Intervention

Immunonutrition

Standard Oral Nutritional Support

About this trial

This is an interventional supportive care trial for Colon Cancer focused on measuring immunonutrition, colon cancer, inflammatory response, perioperative care, randomized controlled trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

2nd Department of General Surgery, Jagiellonian University Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Immuno-group

Control-group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04732442

First Posted

January 19, 2021

Last Updated

January 29, 2021

Sponsor

Jagiellonian University

1. Study Identification

Unique Protocol Identification Number

NCT04732442

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

November 1, 2017 (Actual)

Primary Completion Date

November 30, 2018 (Actual)

Study Completion Date

January 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Jagiellonian University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colon Cancer, Nutrition Aspect of Cancer

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized 2-arm controlled trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Immuno-group

Arm Type

Experimental

Arm Description

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.

Arm Title

Control-group

Arm Type

Sham Comparator

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Immunonutrition

Other Intervention Name(s)

Immunonutrition Oral Nutritional Support

Intervention Description

Impact Oral® Nestle, Switzerland

Intervention Type

Dietary Supplement

Intervention Name(s)

Standard Oral Nutritional Support

Intervention Description

Fortimel Compact Protein® Nutricia, United Kingdom

Primary Outcome Measure Information:

Title

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

Description

Time Frame

up to 13 months

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

up to 13 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michał Pędziwiatr, Prof.

Organizational Affiliation

Jagiellonian University

Official's Role

Principal Investigator

Facility Information:

Facility Name

2nd Department of General Surgery, Jagiellonian University Medical College

City

Kraków

State/Province

Małopolska

ZIP/Postal Code

30-688

Country

Poland

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs