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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa e a Inovação do Estado de Santa Catarina | UNKNOWN |
| Centro de Pesquisas Oncológicas de Florianópolis | UNKNOWN |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fish oil encapsuled | Experimental | will receive the supplementation of 2 g / day of fish oil encapsulated for 9 weeks |
|
| without supplementation | No Intervention | not will receive supplementation or encapsulated fish oil or placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fish oil encapsuled | Dietary Supplement | 2 g/d (4 capsules of 500 mg)for 9 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| change in body composition | 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 | two months |
| change in nutritional status |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michel C Mocellin, Master's | Universidade Federal de Santa Catarina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Pesquisas Oncológicas - CEPON | Florianópolis | Santa Catatina | 88034-000 | Brazil |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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will be measured anthropometric measures: weight and height (baseline and end of study) for the classification of nutritional status according to BMI
| two months |
| Changes in plasma lipid profile | will evaluate the proportion of incorporation of omega-3 fatty acids in plasma | two months |
| assessing the risk of inflammatory and nutritional complications | 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 | two months |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |