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.

据认为，饮食在前列腺癌（美国男性中的一种主要癌症）中发挥着重要作用。 然而，迄今为止，还没有任何饮食干预措施被证明对预防或补充护理有效。 拟议的研究将重点关注亚麻籽补充剂（FS）和低脂饮食（LF），因为我们的试点研究和其他人的研究表明这些因素显着改变前列腺癌的进展。我们的多学科团队由营养学家、泌尿科医生、病理学家和生物统计学家组成，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。 前列腺切除术之前滞后时间超过 3 周的新诊断前列腺癌病例 (N=160) 将被随机分为以下组之一：1) 对照组； 2) FS（30克/天）； LF（小于或等于总能量的 20%）；或 4) FS+LF。 所有受试者都将受到监测并接受饮食指导和用品。增殖率（MIB-1）将作为确定饮食功效的主要终点。 其他终点包括：细胞凋亡指数（TUNEL）、高级前列腺上皮内瘤变的程度和总血清前列腺特异性抗原。 鉴于我们的试点数据表明 FS 和 LF 饮食可能通过激素机制发挥作用，因此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]。还将测量营养生物标志物（即前列腺液和尿液中的木酚素水平，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。拟议的研究旨在为人们对饮食和前列腺肿瘤的了解做出重要贡献。这项研究有可能扩大前列腺癌补充治疗的范围，并可能为预防工作提供坚实的基础。