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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- change in inflammatory markers
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 19 years
- •Histopathological diagnosis of colorectal cancer
- •Beginning of chemotherapy in the target institution
- •Agree to participate in the study [signature of IC]
排除标准
- •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
研究组 & 干预措施
without supplementation
not will receive supplementation or encapsulated fish oil or placebo
fish oil encapsuled
will receive the supplementation of 2 g / day of fish oil encapsulated for 9 weeks
干预措施: fish oil encapsuled (Dietary Supplement)
结局指标
主要结局
change in inflammatory markers
时间窗: 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)
次要结局
- change in body composition(two months)
- change in nutritional status(two months)
- Changes in plasma lipid profile(two months)
- assessing the risk of inflammatory and nutritional complications(two months)
研究者
Erasmo Benicio Santos de Moraes Trindade
Clinical Professor
Universidade Federal de Santa Catarina