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

Study Overview
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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.

Official Title
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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

Conditions
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Colorectal Cancer, Inflammation

Intervention / Treatment
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* Dietary Supplement: fish oil encapsuled


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inflammatory markers, colorectal cancer, cytokines, fish oil