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

This study has been completed.
Sponsor:
Collaborators:
Programa de Pós-Graduação em Nutrição - Universidade Federal de Santa Catarina
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
ClinicalTrials.gov Identifier:
NCT01575340
First received: October 5, 2011
Last updated: September 5, 2012
Last verified: September 2012
History of Changes

October 5, 2011
September 5, 2012
July 2011
May 2012   (final data collection date for primary outcome measure)
change in inflammatory markers [ Time Frame: two months ] [ Designated as safety issue: No ]
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)
change in inflammatory markers [ Time Frame: two months ] [ Designated as safety issue: No ]
will be evaluated cytokines IL-1 beta, IL-10, IL-17A and TNF alpha 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)
Complete list of historical versions of study NCT01575340 on ClinicalTrials.gov Archive Site
  • change in body composition [ Time Frame: two months ] [ Designated as safety issue: No ]
    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
  • change in nutritional status [ Time Frame: two months ] [ Designated as safety issue: No ]
    will be measured anthropometric measures: weight and height (baseline and end of study) for the classification of nutritional status according to BMI
  • Changes in plasma lipid profile [ Time Frame: two months ] [ Designated as safety issue: No ]
    will evaluate the proportion of incorporation of omega-3 fatty acids in plasma
  • assessing the risk of inflammatory and nutritional complications [ Time Frame: two months ] [ Designated as safety issue: No ]
    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
  • change in body composition [ Time Frame: two months ] [ Designated as safety issue: No ]
    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
  • change in nutritional status [ Time Frame: two months ] [ Designated as safety issue: No ]
    will be measured anthropometric measures: weight, height, arm circumference and triceps skinfold, on two occasions (baseline and end of study) for the classification of nutritional status according to BMI and Adequacy of arm circumference and triceps skinfold
  • Changes in cellular lipid profile [ Time Frame: two months ] [ Designated as safety issue: No ]
    will evaluate the proportion of incorporation of omega-3 fatty acids in red blood cells and mononuclear cells from blood.
Not Provided
Not Provided
 
Study to Assess the Effect of Consumption of Fish Oil Encapsulated on Inflammatory Markers in Colorectal Cancer
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

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

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Colorectal Cancer
  • Inflammation
Dietary Supplement: fish oil encapsuled
2 g/d (4 capsules of 500 mg)for 9 weeks
Other Name: omega-3 encapsuled
  • Experimental: fish oil encapsuled
    will receive the supplementation of 2 g / day of fish oil encapsulated for 9 weeks
    Intervention: Dietary Supplement: fish oil encapsuled
  • No Intervention: without supplementation
    not will receive supplementation or encapsulated fish oil or placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
July 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01575340
20.179/2010-0
No
Erasmo Benicio Santos de Moraes Trindade, Universidade Federal de Santa Catarina
Universidade Federal de Santa Catarina
  • Programa de Pós-Graduação em Nutrição - Universidade Federal de Santa Catarina
  • Fundação de Amparo à Pesquisa e a Inovação do Estado de Santa Catarina
  • Centro de Pesquisas Oncológicas de Florianópolis
Principal Investigator: Michel C Mocellin, Master's Universidade Federal de Santa Catarina
Universidade Federal de Santa Catarina
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP