Changes in Inflammatory Response After Immunonutrition Compared to Standard Nutrition in Colorectal Cancer Tissue
NCT ID: NCT04732442
Last Updated: 2021-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2017-11-01
2019-01-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Immuno-group
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.
Immunonutrition
Impact Oral® Nestle, Switzerland
Control-group
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.
Standard Oral Nutritional Support
Fortimel Compact Protein® Nutricia, United Kingdom
Interventions
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Immunonutrition
Impact Oral® Nestle, Switzerland
Standard Oral Nutritional Support
Fortimel Compact Protein® Nutricia, United Kingdom
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Jagiellonian University
OTHER
Responsible Party
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Michał Pędziwiatr
Prof., MD, PhD
Principal Investigators
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Michał Pędziwiatr, Prof.
Role: PRINCIPAL_INVESTIGATOR
Jagiellonian University
Locations
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2nd Department of General Surgery, Jagiellonian University Medical College
Krakow, Małopolska, Poland
Countries
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Other Identifiers
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JagiellonianU-07
Identifier Type: -
Identifier Source: org_study_id
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