Study to Assess the Effect of Consumption of Fish Oil Encapsulated on Inflammatory Markers in Colorectal Cancer

Universidade Federal de Santa Catarina11 enrolled

Overview

The purpose of this study is to evaluate whether supplementation 2g/day encapsulated fish oil modifies inflammatory markers in individuals with colorectal cancer in chemotherapy

The study will recruit patients with newly diagnosed colorectal cancer and that has not yet undergone any chemotherapy treatment. Individuals that meet the inclusion criteria are randomized by means of a computer program on two study groups: 1) supplemented Experimental: receive 2g/day supplementation encapsulated fish oil for 9 weeks. 2) No intervention - control: not receive supplementation of fish oil or placebo. Will be assessed the effects of supplementation on the standard profile of cytokine production, nutritional status, and proportion of incorporation of these fatty acids in blood cells (mononuclear and red blood cells). Blood samples are collected before the start of first chemotherapy and nine weeks later. Supplementation in the experimental group also will start on the first day of chemotherapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Colorectal Cancer Inflammation

Interventions

fish oil encapsuledDIETARY_SUPPLEMENT

2 g/d (4 capsules of 500 mg)for 9 weeks

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 19 years * Histopathological diagnosis of colorectal cancer * Beginning of chemotherapy in the target institution * Agree to participate in the study \[signature of IC\] Exclusion Criteria: * Age \<19 years * Being in palliative care * Inability to oral intake * Allergic to the fish and fish products * Owning with hyperlipidemia requiring drug treatment * Consumption prior to the study of fish oil or supplements containing omega-3 PUFA * Being in medical treatment with some nonsteroidal anti-inflammatory * Have some kind of infection

Locations (1)

Centro de Pesquisas Oncológicas - CEPON

Florianópolis, Santa Catatina, Brazil

Outcomes

Primary Outcomes

change in inflammatory markers

will be evaluated cytokines IL-1 beta, IL-10, IL-17A and TNF alpha, and acute phase proteins CRP and Albumin, in baseline that corresponds to the day that the patient will begin chemotherapy and the final moment, which corresponds to 9 weeks counting from the baseline in both groups (supplemented and non-supplemented)

Time frame: two months

Secondary Outcomes

change in body composition

will estimate the percentage of body fat in each patient through the use of skinfold thickness at baseline and end to study in both groups

Time frame: two months

change in nutritional status

will be measured anthropometric measures: weight and height (baseline and end of study) for the classification of nutritional status according to BMI

Time frame: two months

Changes in plasma lipid profile

will evaluate the proportion of incorporation of omega-3 fatty acids in plasma

Time frame: two months

assessing the risk of inflammatory and nutritional complications

Will be calculated the ratio PCR / albumin, as proposed by Correa et al., 2002, using the cutoff points proposed by the same author for the classification of high, medium, decreased or no risk

Time frame: two months

Data from ClinicalTrials.gov

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