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

Not Applicable

Completed

• Conditions: Colorectal Cancer; Inflammation
• Interventions: Dietary Supplement: fish oil encapsuled

• Registration Number: NCT01575340
• Lead Sponsor: Universidade Federal de Santa Catarina

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-10-05
• Study First Submitted QC: 2012-04-10
• Study First Posted: 2012-04-11
• Primary Completion: 2012-05
• Study Completion: 2012-07
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-05
• Last Update Posted: 2012-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fish oil encapsuled	fish oil encapsuled	will receive the supplementation of 2 g / day of fish oil encapsulated for 9 weeks

Primary Outcome Measures

Name	Time	Method
change in inflammatory markers	two months	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)

Secondary Outcome Measures

Name	Time	Method
change in body composition	two months	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
change in nutritional status	two months	will be measured anthropometric measures: weight and height (baseline and end of study) for the classification of nutritional status according to BMI
Changes in plasma lipid profile	two months	will evaluate the proportion of incorporation of omega-3 fatty acids in plasma
assessing the risk of inflammatory and nutritional complications	two months	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

Trial Locations

Locations (1)

Centro de Pesquisas Oncológicas - CEPON; 🇧🇷 Florianópolis, Santa Catatina, Brazil