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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


N/A
19 Years
N/A
Not Enrolling
Both
Colorectal Cancer, Inflammation

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

change in inflammatory markers

Outcome 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)

Outcome Time Frame:

two months

Safety Issue:

No

Principal Investigator

Michel C Mocellin, Master's

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universidade Federal de Santa Catarina

Authority:

Brazil: National Health Surveillance Agency

Study ID:

20.179/2010-0

NCT ID:

NCT01575340

Start Date:

July 2011

Completion Date:

July 2012

Related Keywords:

  • Colorectal Cancer
  • Inflammation
  • inflammatory markers
  • colorectal cancer
  • cytokines
  • fish oil
  • Colorectal Neoplasms
  • Inflammation

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