The Effects of Omega-3 Fatty Acids on Chemotherapy-induced Neuropathy and Inflammation in Patients With Breast Cancer
试验速览
- 阶段
- 4 期
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- The EMG-NCV test,The serum level of IL-1,IL-6,TNF-alpha and hs-CRP
研究概览
简要总结
The aim of this study is to assess the effects of n-3 fatty acids on taxane-induced neuropathy and neurotoxic inflammatory agents in patients suffering from invasive breast cancer.
详细描述
Breast cancer is the most common malignancy in women. Chemotherapy with taxanes in patients with breast cancer causes some complications and neuropathy is one of the most frequent that is dose limiting and even may cause to stop the therapy. n-3 fatty acids have very significant role in improvement the function of the neurons.n-3 fatty acids decrease the demyelination and toxicities resulting from taxanes. They also lower the level of of the neurotoxic inflammatory agents. So,n-3 fatty acids improve the quality of life in this patients. 52 patients with invasive breast cancer will be randomized in a double-blind placebo-controlled manner to receive either 640 mg oil fish pearls( 54% DHA, 10% EPA) 3 times a day or placebo( corn oil pearls) for 3 months(during the chemotherapy with taxanes). Neuropathy (using EMG-NCV test)and the level of IL-1,IL-6, TNF-alpha, hs-crp and serum level of EPA and DHA fatty acids will be measured before chemotherapy with taxanes and at the end of the therapy (after 3 months).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Suffering from invasive breast cancer,not receiving any form of supplementations and oil fish
排除标准
- •Suffering from the diseases leading to neuropathy, e.g.diabetes, hyperthyroidism, AIDS and primary neural diseases
- •Suffering from any other kind of malignancies
- •Receiving any chemotherapeutical agents in the past
结局指标
主要结局
The EMG-NCV test,The serum level of IL-1,IL-6,TNF-alpha and hs-CRP
时间窗: first day and after 3 months (before chemotherapy with taxanes and at the end of the therapy
次要结局
- The serum level of DHA and EPA fatty acids(first day and after 3 months( before chemotherapy with taxanes and at the end of the therapy)
研究者
Zohreh Ghoreishi
Master of Nutrition
Tehran University of Medical Sciences
