OMEGA 3 FATTY ACIDS SUPPLEMENTS IN WOMEN AT HIGH RISK FOR BREAST CANCER

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 根据细胞培养和啮齿动物研究，omega 3脂肪酸可以防止乳腺癌的生长和发展。来自我们实验室的最新数据表明，只有某些乳腺癌可能会对饮食中脂肪类型的差异产生反应。然而，为了研究omega 3脂肪酸对人类乳腺癌的影响，还需要更多关于高危和乳腺癌患者服用特定剂量omega 3脂肪酸膳食补充剂的毒性、耐受性和乳房组织摄取的信息。因此，我们建议对乳腺癌高危患者进行6个月的omega-3脂肪酸剂量-反应研究，使用4种不同剂量的高浓度omega-3脂肪酸补充剂(Omacor)。这项研究是迈向omega 3脂肪酸预防和/或治疗乳腺癌的更大规模、长期临床试验的重要第一步。 在0个月、3个月和6个月时，通过细针抽吸获得的乳房脂肪样本将被检查脂肪酸含量的变化，以及每月的血液样本，以监测目前的饮食脂肪酸摄入量。将在0、3和6个月时采集血样，以确定对血脂、血小板功能、肝功能的影响，以及乳腺癌风险和/或omega 3脂肪酸的潜在生物标记物。患者将通过每天记入日志并与研究人员定期沟通来监测不良事件。3天的饮食记录和食物频率问卷将用于监测日常饮食。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Based on cell culture and rodent studies, omega 3 fatty acids prevent the growth and development of breast cancer. Recent data from our laboratory indicate the possibility that only certain breast cancers may respond to differences in the type of fat in the diet. In order to study the effects of omega 3 fatty acids on human breast cancer, however, additional information is needed regarding toxicity, tolerability and breast tissue uptake associated with specific doses of omega 3 fatty acid dietary supplements in high risk and breast cancer patients. Therefore, we propose a 6 month dose-response study of omega 3 fatty acids in patients at high risk of developing breast cancer, utilizing 4 different doses of a highly concentrated omega 3 fatty acid supplement (Omacor). This study is an essential first step towards larger, long term clinical trials of omega 3 fatty acids for breast cancer prevention and/or therapy. Breast fat samples obtained by fine needle aspiration at 0, 3 and 6 months will be checked for changes in fatty acid content, along with monthly blood samples to monitor current dietary fatty acid intake. Blood samples will be obtained at 0, 3 and 6 months to determine effects on lipid profile, platelet function, liver function, and potential biomarkers of breast cancer risk and/or omega 3 fatty acids. Patients will be monitored for adverse events via daily entries into logbooks and regular communication with study personnel. 3 day diet records and food frequency questionnaires will be used to monitor usual diets.