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

• ClinicalTrials.gov Identifier: NCT01575340
• Recruitment Status: Completed
• First Posted: April 11, 2012
• Last Update Posted: September 6, 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
• Information provided by (Responsible Party): Erasmo Benicio Santos de Moraes Trindade, Universidade Federal de Santa Catarina

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

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Principal Investigator: Michel C Mocellin, Master's; Universidade Federal de Santa Catarina

More Information

• 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
• 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:

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