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

Universidade Federal de Santa Catarina

Status: Completed

Conditions: Inflammation; Colorectal Cancer

Treatments: Dietary Supplement: fish oil encapsuled

Study type: Interventional

Funder types: Other

Identifiers

NCT01575340

20.179/2010-0

Details and patient eligibility

About

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

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

fish oil encapsuled

Experimental group

Description:

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

Treatment:

Dietary Supplement: fish oil encapsuled

without supplementation

No Intervention group

Description:

not will receive supplementation or encapsulated fish oil or placebo