Study to Assess the Effect of Consumption of Fish Oil Encapsulated on Inflammatory Markers in Colorectal Cancer
Primary Purpose
Colorectal Cancer, Inflammation
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
fish oil encapsuled
Sponsored by
About this trial
This is an interventional supportive care trial for Colorectal Cancer focused on measuring inflammatory markers, colorectal cancer, cytokines, fish oil
Eligibility 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
Sites / Locations
- Centro de Pesquisas Oncológicas - CEPON
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
fish oil encapsuled
without supplementation
Arm Description
will receive the supplementation of 2 g / day of fish oil encapsulated for 9 weeks
not will receive supplementation or encapsulated fish oil or placebo
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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
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
Changes in plasma lipid profile
will evaluate the proportion of incorporation of omega-3 fatty acids in plasma
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
Full Information
NCT ID
NCT01575340
First Posted
October 5, 2011
Last Updated
September 5, 2012
Sponsor
Universidade Federal de Santa Catarina
Collaborators
Fundação de Amparo à Pesquisa e a Inovação do Estado de Santa Catarina, Centro de Pesquisas Oncológicas de Florianópolis
1. Study Identification
Unique Protocol Identification Number
NCT01575340
Brief Title
Study to Assess the Effect of Consumption of Fish Oil Encapsulated on Inflammatory Markers in Colorectal Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Santa Catarina
Collaborators
Fundação de Amparo à Pesquisa e a Inovação do Estado de Santa Catarina, Centro de Pesquisas Oncológicas de Florianópolis
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Inflammation
Keywords
inflammatory markers, colorectal cancer, cytokines, fish oil
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
fish oil encapsuled
Arm Type
Experimental
Arm Description
will receive the supplementation of 2 g / day of fish oil encapsulated for 9 weeks
Arm Title
without supplementation
Arm Type
No Intervention
Arm Description
not will receive supplementation or encapsulated fish oil or placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
fish oil encapsuled
Other Intervention Name(s)
omega-3 encapsuled
Intervention Description
2 g/d (4 capsules of 500 mg)for 9 weeks
Primary Outcome Measure Information:
Title
change in inflammatory markers
Description
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)
Time Frame
two months
Secondary Outcome Measure Information:
Title
change in body composition
Description
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
Time Frame
two months
Title
change in nutritional status
Description
will be measured anthropometric measures: weight and height (baseline and end of study) for the classification of nutritional status according to BMI
Time Frame
two months
Title
Changes in plasma lipid profile
Description
will evaluate the proportion of incorporation of omega-3 fatty acids in plasma
Time Frame
two months
Title
assessing the risk of inflammatory and nutritional complications
Description
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
Time Frame
two months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel C Mocellin, Master's
Organizational Affiliation
Universidade Federal de Santa Catarina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Pesquisas Oncológicas - CEPON
City
Florianópolis
State/Province
Santa Catatina
ZIP/Postal Code
88034-000
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Study to Assess the Effect of Consumption of Fish Oil Encapsulated on Inflammatory Markers in Colorectal Cancer
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