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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01575340
• Other study ID #: 20.179/2010-0
• Status: Completed
• Phase: N/A
• First received: October 5, 2011
• Last updated: September 5, 2012
• Start date: July 2011
• Est. completion date: July 2012

Study information

• Verified date: September 2012
• Source: Universidade Federal de Santa Catarina
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: July 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Inflammation

Intervention

Dietary Supplement:
• fish oil encapsuled
2 g/d (4 capsules of 500 mg)for 9 weeks

Locations

Country	Name	City	State
Brazil	Centro de Pesquisas Oncológicas - CEPON	Florianópolis	Santa Catatina

Sponsors (3)

Lead Sponsor	Collaborator
Universidade Federal de Santa Catarina	Centro de Pesquisas Oncológicas de Florianópolis, Fundação de Amparo à Pesquisa e a Inovação do Estado de Santa Catarina

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Changes in plasma lipid profile	will evaluate the proportion of incorporation of omega-3 fatty acids in plasma	two months	No
Secondary	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	No