Oncology Unit, Centre de recherche du CHU de Québec - Université Laval - L'Hôtel-Dieu de Québec, 6 rue McMahon, Québec, QC, Canada.
Mathematics and Statistics Department, Université Laval, 1045 avenue de la médecine, Bureau, Québec, QC, 1056, Canada.
BMC Cancer. 2018 Jan 10;18(1):64. doi: 10.1186/s12885-017-3979-9.
Prostate cancer is the most commonly diagnosed cancer in north-American men. Few dietary or lifestyle interventions have been tested to prevent prostate cancer progression. Omega-3 fatty acid supplementation represents a promising intervention for prostate cancer patients. The aim of the study is to evaluate the effects of long-chain omega-3 polyunsaturated fatty acids (LCn3), more precisely eicosapentaenoic acid monoacylglyceride (MAG-EPA) supplementation, on prostate cancer proliferation, inflammation mediators and quality of life among men who will undergo radical prostatectomy.
METHODS/DESIGN: We propose a phase IIb, randomized, double-blind placebo-controlled trial of MAG-EPA supplementation for 130 men who will undergo radical prostatectomy as treatment for a prostate cancer of Gleason score ≥ 7 in an academic cancer center in Quebec City. Participants will be randomized to 6 capsules of 625 mg of fish oil (MAG-EPA) per capsule containing 500 mg of EPA daily or to identically looking capsules of high oleic acid sunflower oil (HOSO) as placebo. The intervention begins 4 to 10 weeks prior to radical prostatectomy (baseline) and continues for one year after surgery. The primary endpoint is the proliferative index (Ki-67) measured in prostate cancer cells at radical prostatectomy. A secondary endpoint includes prostate tissue levels of inflammatory mediators (cytokines and proteins) at time of radical prostatectomy. Changes in blood levels of inflammatory mediators, relative to baseline levels, at time of radical prostatectomy and 12 months after radical prostatectomy will also be evaluated. Secondary endpoints also include important aspects of psychosocial functioning and quality of life such as depression, anxiety, sleep disturbances, fatigue, cognitive complaints and prostate cancer-specific quality of life domains. The changes in these outcomes, relative to baseline levels, will be evaluated at 3, 6, 9 and 12 months after radical prostatectomy.
The results from this trial will provide crucial information to clarify the role of omega-3 supplementation on prostate cancer proliferation, inflammation and quality of life.
ClinicalTrials.gov Identifier: NCT02333435. Registered on December 17, 2014. Last updated September 6, 2016.
前列腺癌是北美男性最常见的癌症。很少有饮食或生活方式干预措施被测试用于预防前列腺癌的进展。ω-3 脂肪酸补充剂代表了一种有前途的前列腺癌患者干预措施。本研究的目的是评估长链 ω-3 多不饱和脂肪酸（LCn3），更准确地说是二十碳五烯酸单酰甘油（MAG-EPA）补充剂，对将接受根治性前列腺切除术的男性的前列腺癌增殖、炎症介质和生活质量的影响。
方法/设计：我们提出了一项 IIb 期、随机、双盲、安慰剂对照试验，研究 MAG-EPA 补充剂在魁北克市一家学术癌症中心接受根治性前列腺切除术治疗 Gleason 评分≥7 的前列腺癌的 130 名男性中的应用。参与者将被随机分配至每天 6 粒 625mg 的鱼油（MAG-EPA）胶囊，每粒胶囊含 500mg EPA，或同样外观的高油酸葵花籽油（HOSO）胶囊作为安慰剂。干预措施在根治性前列腺切除术前 4 至 10 周（基线）开始，并在手术后持续一年。主要终点是在根治性前列腺切除术中测量前列腺癌细胞的增殖指数（Ki-67）。次要终点包括在根治性前列腺切除时前列腺组织中炎症介质（细胞因子和蛋白质）的水平。还将评估在根治性前列腺切除术时和根治性前列腺切除术 12 个月后血液中炎症介质相对于基线水平的变化。次要终点还包括心理社会功能和生活质量的重要方面，如抑郁、焦虑、睡眠障碍、疲劳、认知主诉和前列腺癌特异性生活质量领域。将在根治性前列腺切除术后 3、6、9 和 12 个月评估这些结局相对于基线水平的变化。
该试验的结果将提供重要信息，以阐明 ω-3 补充剂对前列腺癌增殖、炎症和生活质量的作用。
ClinicalTrials.gov 标识符：NCT02333435。于 2014 年 12 月 17 日注册。最后更新于 2016 年 9 月 6 日。
