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临床试验/NCT01049295
NCT01049295Unknown4 期

The Effects of Omega-3 Fatty Acids on Chemotherapy-induced Neuropathy and Inflammation in Patients With Breast Cancer

Tehran University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2010年4月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zohreh Ghoreishi

Master of Nutrition

Tehran University of Medical Sciences

研究点 (1)

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