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

NCT ID: NCT01575340

Last Updated: 2012-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-07-31

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer Inflammation

Keywords

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inflammatory markers colorectal cancer cytokines fish oil

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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fish oil encapsuled

will receive the supplementation of 2 g / day of fish oil encapsulated for 9 weeks

Group Type EXPERIMENTAL

fish oil encapsuled

Intervention Type DIETARY_SUPPLEMENT

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

without supplementation

not will receive supplementation or encapsulated fish oil or placebo

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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fish oil encapsuled

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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omega-3 encapsuled

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa e a Inovação do Estado de Santa Catarina

UNKNOWN

Sponsor Role collaborator

Centro de Pesquisas Oncológicas de Florianópolis

UNKNOWN

Sponsor Role collaborator

Universidade Federal de Santa Catarina

OTHER

Sponsor Role lead

Responsible Party

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Erasmo Benicio Santos de Moraes Trindade

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michel C Mocellin, Master's

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de Santa Catarina

Locations

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Centro de Pesquisas Oncológicas - CEPON

Florianópolis, Santa Catatina, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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20.179/2010-0

Identifier Type: -

Identifier Source: org_study_id