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

Jagiellonian University

Status: Completed

Conditions: Colon Cancer; Nutrition Aspect of Cancer

Treatments: Dietary Supplement: Standard Oral Nutritional Support; Dietary Supplement: Immunonutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT04732442

JagiellonianU-07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Immuno-group

Experimental group

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.

Treatment:

Dietary Supplement: Immunonutrition

Control-group

Sham Comparator group

Description:

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.

Treatment:

Dietary Supplement: Standard Oral Nutritional Support