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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01575340
Recruitment Status : Completed
First Posted : April 11, 2012
Last Update Posted : September 6, 2012
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa e a Inovação do Estado de Santa Catarina
Centro de Pesquisas Oncológicas de Florianópolis
Information provided by (Responsible Party):
Erasmo Benicio Santos de Moraes Trindade, Universidade Federal de Santa Catarina

Brief 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

Condition or disease Intervention/treatment Phase
Colorectal Cancer Inflammation Dietary Supplement: fish oil encapsuled Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Study Start Date : July 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil

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 Name: omega-3 encapsuled

No Intervention: without supplementation
not will receive supplementation or encapsulated fish oil or placebo



Primary Outcome Measures :
  1. change in inflammatory markers [ Time Frame: two months ]
    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)


Secondary Outcome Measures :
  1. change in body composition [ Time Frame: two months ]
    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

  2. change in nutritional status [ Time Frame: two months ]
    will be measured anthropometric measures: weight and height (baseline and end of study) for the classification of nutritional status according to BMI

  3. Changes in plasma lipid profile [ Time Frame: two months ]
    will evaluate the proportion of incorporation of omega-3 fatty acids in plasma

  4. assessing the risk of inflammatory and nutritional complications [ Time Frame: two months ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575340


Locations
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Brazil
Centro de Pesquisas Oncológicas - CEPON
Florianópolis, Santa Catatina, Brazil, 88034-000
Sponsors and Collaborators
Universidade Federal de Santa Catarina
Fundação de Amparo à Pesquisa e a Inovação do Estado de Santa Catarina
Centro de Pesquisas Oncológicas de Florianópolis
Investigators
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Principal Investigator: Michel C Mocellin, Master's Universidade Federal de Santa Catarina
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Responsible Party: Erasmo Benicio Santos de Moraes Trindade, Clinical Professor, Universidade Federal de Santa Catarina
ClinicalTrials.gov Identifier: NCT01575340    
Other Study ID Numbers: 20.179/2010-0
First Posted: April 11, 2012    Key Record Dates
Last Update Posted: September 6, 2012
Last Verified: September 2012
Keywords provided by Erasmo Benicio Santos de Moraes Trindade, Universidade Federal de Santa Catarina:
inflammatory markers
colorectal cancer
cytokines
fish oil
Additional relevant MeSH terms:
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Colorectal Neoplasms
Inflammation
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pathologic Processes