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

NCT01575340 | Completed

• 1 other identifier: 20.179/2010-0
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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

Conditions

Colorectal Cancer; Inflammation

Keywords

inflammatory markers; colorectal cancer; cytokines; fish oil

Outcome Measures

Primary Outcomes (1)

• 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)

  two months

Secondary Outcomes (4)

• change in body composition

  two months

• change in nutritional status

  two months

• Changes in plasma lipid profile

  two months

• assessing the risk of inflammatory and nutritional complications

  two months

Study Arms (2)

fish oil encapsuled

EXPERIMENTAL

will receive the supplementation of 2 g / day of fish oil encapsulated for 9 weeks

Dietary Supplement: fish oil encapsuled

without supplementation

NO INTERVENTION

not will receive supplementation or encapsulated fish oil or placebo

Interventions

fish oil encapsuled DIETARY_SUPPLEMENT

2 g/d (4 capsules of 500 mg)for 9 weeks

Also known as: omega-3 encapsuled

fish oil encapsuled

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 19 years
• Histopathological diagnosis of colorectal cancer
• Beginning of chemotherapy in the target institution
• Agree to participate in the study \[signature of IC\]

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal de Santa Catarina: lead
• Fundação de Amparo à Pesquisa e a Inovação do Estado de Santa Catarina: collaborator
• Centro de Pesquisas Oncológicas de Florianópolis: collaborator

Study Sites (1)

Centro de Pesquisas Oncológicas - CEPON

Florianópolis, Santa Catatina, 88034-000, Brazil

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Inflammation

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michel C Mocellin, Master's

  Universidade Federal de Santa Catarina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 5, 2011
• First Posted: April 11, 2012
• Study Start: July 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: July 1, 2012
• Last Updated: September 6, 2012

Record last verified: 2012-09

Locations

BR (1)