Clinical trial NCT01575340: 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
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Inflammation
Keywords: inflammatory markers
colorectal cancer
cytokines
fish oil
Lead sponsor: Universidade Federal de Santa Catarina
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa e a Inovação do Estado de Santa Catarina
name: Centro de Pesquisas Oncológicas de Florianópolis
First posted: 2012-04-11
Enrollment: 11
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: change in inflammatory markers
timeFrame: two months
Secondary outcomes:
measure: change in body composition
timeFrame: two months
measure: change in nutritional status
timeFrame: two months
measure: Changes in plasma lipid profile
timeFrame: two months
measure: assessing the risk of inflammatory and nutritional complications
timeFrame: two months
Other outcomes:
Locations:
city: Florianópolis
country: Brazil
facility: Centro de Pesquisas Oncológicas - CEPON
state: Santa Catatina
Study officials:
affiliation: Universidade Federal de Santa Catarina
name: Michel C Mocellin, Master's
role: PRINCIPAL_INVESTIGATOR
References: