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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 11
- Locations
- 2
- Primary Endpoint
- change in inflammatory markers
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
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 Outcomes
- change in nutritional status(two months)
- change in body composition(two months)
- Changes in plasma lipid profile(two months)
- assessing the risk of inflammatory and nutritional complications(two months)
Investigators
Erasmo Benicio Santos de Moraes Trindade
Clinical Professor
Universidade Federal de Santa Catarina