Study to Assess the Effect of Consumption of Fish Oil Encapsulated on Inflammatory Markers in Colorectal Cancer
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ClinicalTrials.gov Identifier: NCT01575340 |
Recruitment Status :
Completed
First Posted : April 11, 2012
Last Update Posted : September 6, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colorectal Cancer Inflammation | Dietary Supplement: fish oil encapsuled | Not Applicable |
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.
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 |

Arm | Intervention/treatment |
---|---|
Experimental: fish oil encapsuled
will receive the supplementation of 2 g / day of fish oil encapsulated for 9 weeks
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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
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- 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)
- 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
- 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
- Changes in plasma lipid profile [ Time Frame: two months ]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 ]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

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

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
Brazil | |
Centro de Pesquisas Oncológicas - CEPON | |
Florianópolis, Santa Catatina, Brazil, 88034-000 |
Principal Investigator: | Michel C Mocellin, Master's | Universidade Federal de Santa Catarina |
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 |
inflammatory markers colorectal cancer cytokines fish oil |
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 |