Prostate Cancer: Impact of Fat & Flaxseed Modified Diet

前列腺癌：脂肪的影响

• 批准号: 6438010
• 负责人: WENDY DEMARK-WAHNEFRIED
• 金额: $ 32.12万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-01-04 至 2005-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6438010
• 关键词: adult human (21+); apoptosis; biomarker; blood tests; cancer prevention; clinical trials; combination cancer therapy; dietary lipid; dietary restriction; histopathology; hormone regulation /control mechanism; human subject; human therapy evaluation; insulinlike growth factor; male; neoplasm /cancer nutrition therapy; neoplastic process; nutrition aspect of cancer; nutrition related tag; patient oriented research; plant extracts; prostate neoplasms; prostate specific antigen; terminal nick end labeling; testosterone; urinalysis

Diet is presumed to play a major role in prostate cancer - a leading cancer among American men. Yet, to date there are no dietary interventions with proven efficacy for either prevention or complementary care. The proposed study will focus on flaxseed supplementation (FS) and a low fat diet (LF), since our pilot studies and the research of others suggest that these factors significantly alter prostate cancer progression. Our multidisciplinary team of nutritionists, urologists, pathologists and biostatistians propose a controlled clinical trial to test the effects of FS and LF on prostatic neoplasia and also explore potential hormonal mechanisms. Newly diagnosed, prostate cancer cases (N=160) who have greater than 3-week lag- time prior to prostatectomy will be block randomized into one of the following groups: 1) control; 2) FS (30 g/day); LF (less than or equal to 20 percent total energy); or 4) FS+LF. All subjects will be monitored and receive dietary instruction and supplies. Proliferation rate (MIB-1) will serve as the primary endpoint to determine diet efficacy. Other endpoints include: apoptotic index (TUNEL), extent of high grade prostatic intraepithelial neoplasia and total serum prostate specific antigen. Given our pilot data which suggest that FS and LF diets may operate via a hormonal mechanism, potential hormonal mediators also will be assessed [i.e., total serum testosterone, free androgen index, insulin-like growth factor-1 (IGF-1) and IGF binding protein-3]. Nutritional biomarkers (i.e., lignan levels in prostatic fluid and urine, and erythrocyte and prostate fatty acid profiles) also will be measured. Associations between nutritional biomarkers, hormonal mediators and study endpoints will be determined. The proposed study is structured to make an important contribution to what is known about diet and prostatic neoplasia. This research has the potential to expand the scope of complementary treatment offered for prostate cancer, and may provide a solid foundation for efforts aimed at prevention.

据推测，饮食在前列腺癌中起着重要作用-前列腺癌是美国男性的主要癌症。 然而，迄今为止，无论是预防还是补充护理，都没有经证实有效的饮食干预措施。 拟议的研究将集中在亚麻籽补充剂（FS）和低脂饮食（LF），因为我们的试点研究和其他研究表明，这些因素显着改变前列腺癌的进展。我们由营养学家、泌尿科医生、病理学家和生物统计学家组成的多学科团队提出了一项对照临床试验，以测试FS和LF对前列腺肿瘤的影响，并探索潜在的激素机制。 在前列腺切除术前具有大于3周滞后时间的新诊断的前列腺癌病例（N=160）将被区组随机分配到以下组之一：1）对照; 2）FS（30 g/天）; LF（小于或等于总能量的20%）;或4）FS+LF。 将对所有受试者进行监测，并接受饮食指导和供应。增殖率（MIB-1）将作为确定饮食疗效的主要终点。 其他终点包括：凋亡指数（TUNEL），高度前列腺上皮内瘤变的程度和总血清前列腺特异性抗原。 鉴于我们的试验数据表明FS和LF饮食可能通过激素机制起作用，还将评估潜在的激素介质[即，血清总睾酮、游离雄激素指数、胰岛素样生长因子-1（IGF-1）和IGF结合蛋白-3]。营养生物标志物（即，还将测量前列腺液和尿中的木酚素水平，以及红细胞和前列腺脂肪酸谱）。 将确定营养生物标志物、激素介质和研究终点之间的关联。拟议的研究结构，使一个重要的贡献是什么是已知的饮食和前列腺肿瘤。这项研究有可能扩大为前列腺癌提供的补充治疗的范围，并可能为预防工作提供坚实的基础。