Colorectal Cancer, Inflammation
Conditions
Keywords
inflammatory markers, colorectal cancer, cytokines, fish oil
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.
Interventions
DIETARY_SUPPLEMENTfish oil encapsuled
2 g/d (4 capsules of 500 mg)for 9 weeks
Sponsors
Fundação de Amparo à Pesquisa e a Inovação do Estado de Santa Catarina
Centro de Pesquisas Oncológicas de Florianópolis
Universidade Federal de Santa Catarina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in inflammatory markers | 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
| Measure | Time frame | Description |
|---|---|---|
| change in body composition | 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 |
| change in nutritional status | two months | will be measured anthropometric measures: weight and height (baseline and end of study) for the classification of nutritional status according to BMI |
| Changes in plasma lipid profile | two months | will evaluate the proportion of incorporation of omega-3 fatty acids in plasma |
| assessing the risk of inflammatory and nutritional complications | 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 |
Countries
Brazil
Outcome results
None listed