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

Markers of the Inflammatory Response (IL-1β, IL-10, IL-17A and TNF-α) in Patients With Colorectal Cancer in Chemotherapy Supplemented With Fish Oil

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

Study Overview

• Status: Completed
• Conditions: Inflammation; Colorectal Cancer
• Intervention / Treatment: Dietary supplement: fish oil encapsuled

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 Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Santa Catatina
    • Florianópolis, Santa Catatina, Brazil, 88034-000
      • Centro de Pesquisas Oncológicas - CEPON

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: fish oil encapsuled; will receive the supplementation of 2 g / day of fish oil encapsulated for 9 weeks	Dietary supplement: fish oil encapsuled; 2 g/d (4 capsules of 500 mg)for 9 weeks; Other Names: omega-3 encapsuled
No Intervention: without supplementation; not will receive supplementation or encapsulated fish oil or placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	two months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	two months
Changes in plasma lipid profile	will evaluate the proportion of incorporation of omega-3 fatty acids in plasma	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	two months

Collaborators and Investigators

• Sponsor: Universidade Federal de Santa Catarina
• Collaborators: Fundação de Amparo à Pesquisa e a Inovação do Estado de Santa Catarina; Centro de Pesquisas Oncológicas de Florianópolis
• Investigators: Principal Investigator: Michel C Mocellin, Master's, Universidade Federal de Santa Catarina

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: October 5, 2011
• First Submitted That Met QC Criteria: April 10, 2012
• First Posted (Estimate): April 11, 2012

Study Record Updates

• Last Update Posted (Estimate): September 6, 2012
• Last Update Submitted That Met QC Criteria: September 5, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: colorectal cancer; cytokines; inflammatory markers; fish oil
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Inflammation; Colorectal Neoplasms
• Other Study ID Numbers: 20.179/2010-0