A Randomized Clinical Trial of Exercise for Men with Metastatic Prostate Cancer

对患有转移性前列腺癌的男性进行运动的随机临床试验

• 批准号: 8892916
• 负责人: Stacey Kenfield
• 金额: $ 17.24万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-01 至 2017-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8892916
• 关键词: Adherence; Adverse effects; Adverse event; Aerobic; Aerobic Exercise; Affect; Albumins; Alkaline Phosphatase; Androgens; Animal Model; Biological Markers; Body Composition; California; Cancer Etiology; Caring; Castration; Cessation of life; Clinical; Clinical Management; Clinical Trials; Data; Development; Diagnosis; Disease; Disease Progression; Eastern Cooperative Oncology Group; Educational Materials; Ensure; Epidemiology; Exercise; Exercise Physiology; Fatigue; Goals; Growth; Guidelines; Heart Rate; Hemoglobin; Individual; Intervention; Lactate Dehydrogenase; Life; Malignant Neoplasms; Malignant neoplasm of prostate; Metastatic Prostate Cancer; Morbidity - disease rate; Muscle; Neoplasm Metastasis; Nomograms; Oncologist; Opioid Analgesics; Outcome; Pain; Patients; Performance Status; Physical Function; Population; Prognostic Marker; Prostate Cancer therapy; Prostate-Specific Antigen; Public Health; Quality of life; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Relative (related person); Reporting; Resistance; Risk; Safety; San Francisco; Site; Supervision; Symptoms; Toxic effect; United States; Universities; Walking; Weight-Bearing state; arm; base; bone; castration resistant prostate cancer; clinically relevant; deprivation; design; experience; improved; men; mortality; multidisciplinary; oncology; outcome forecast; patient population; post intervention; prognostic; programs; public health relevance; success; treatment as usual; tumor progression; week trial

 DESCRIPTION (provided by applicant): Prostate cancer is the second leading cause of cancer death among men in the United States (US), with ~30,000 deaths expected in 2014. Most morbidity and nearly all mortality due to prostate cancer occur once the disease metastasizes to bone and becomes castration-resistant (mCRPC); the expected survival of men with mCRPC is 2-4 years. Identifying low-toxicity interventions that improve outcomes in this population is a high priority and has the potential to have a large impact on the clinical and public health burden of prostate cancer. Exercise may be an ideal non-pharmacologic therapy for men with mCRPC; many men with mCRPC are able to be physically active, and exercise may minimize treatment-related morbidity and disease progression. Men with mCRPC are generally excluded from exercise trials due to safety concerns, but supervised resistance exercise was recently reported to be safe and improve quality-of-life among 20 Australian men with metastatic prostate cancer. It remains unknown whether supervised aerobic exercise is safe and feasible or whether aerobic or resistance exercise affect prognosis in men with mCRPC. Furthermore, no prior study has compared the safety and efficacy of aerobic vs. resistance exercise in mCRPC. With a long- term goal of conducting a definitive randomized controlled trial evaluating the efficacy of exercise to minimize morbidity and delay death among men with mCRPC, we propose a pilot 3-arm (aerobic, resistance, usual care) 12-week randomized controlled trial among 75 men with mCRPC. Both the aerobic and resistance exercise programs minimize compressive and shear loads on sites of metastases, and consist of 35-60 minutes of exercise three days per week under supervision of an exercise physiologist. The resistance arm will perform up to 3 sets of 6-10 reps of exercises targeting major trunk, upper body, and lower body muscle groups; the aerobic arm will perform treadmill walking or stationary cycling at 60-85% estimated maximal heart rate; and the control arm will receive standard-of-care. All men will receive educational materials at baseline. Our aims are to investigate whether supervised aerobic or resistance exercise is safe and feasible among men with mCRPC; whether these modes of exercise improve a validated prognostic score (based on circulating biomarkers and clinical factors) compared to usual care; whether supervised aerobic or resistance exercise impact fatigue, physical function, and quality-of-life compared to usual care; and whether resistance exercise has a greater effect on the prognostic score and quality-of-life than aerobic exercise among men with mCRPC. The results of this pilot randomized controlled trial will directly inform the design of a large, definitive trial examining the effect f exercise on disease-free and overall survival among men with mCRPC. Such a trial will facilitate the development and implementation of exercise programs for men with mCRPC, directly inform clinical guidelines, and improve the clinical management of metastatic prostate cancer.

 描述（由申请人提供）：前列腺癌是美国（US）男性癌症死亡的第二大原因，预计2014年约有30，000例死亡。一旦疾病转移到骨并成为去势抵抗性（mCRPC），前列腺癌导致的大多数发病率和几乎所有死亡率都会发生; mCRPC男性患者的预期生存期为2-4年。确定改善这一人群结局的低毒性干预措施是一个高度优先事项，并有可能对前列腺癌的临床和公共卫生负担产生重大影响。运动可能是mCRPC男性患者的理想非药物治疗;许多mCRPC男性患者能够进行体力活动，运动可最大限度地减少治疗相关的发病率和疾病进展。由于安全性问题，患有mCRPC的男性通常被排除在运动试验之外，但最近报告称，在20名患有转移性前列腺癌的澳大利亚男性中，监督阻力运动是安全的，并改善了生活质量。目前尚不清楚有监督的有氧运动是否安全可行，或者有氧运动或抗阻运动是否会影响mCRPC男性患者的预后。此外，既往没有研究比较有氧运动与抗阻运动在mCRPC中的安全性和疗效。长期目标是进行一项明确的随机对照试验，评价运动在最大限度降低mCRPC男性患者发病率和延迟死亡方面的疗效，我们提出了一项在75例mCRPC男性患者中进行的试点3组（有氧、阻力、常规护理）12周随机对照试验。有氧运动和抗阻运动计划都最大限度地减少了转移部位的压缩和剪切负荷，并在运动生理学家的监督下每周三天进行35-60分钟的运动。阻力臂将针对主要躯干、上身和下身肌肉群进行最多3组6-10次重复的运动;有氧臂将以60-85%的估计最大心率进行跑步机行走或静止自行车运动;对照臂将接受标准治疗。所有男性将在基线时收到教育材料。我们的目的是研究在有监督的有氧运动或抗阻运动对mCRPC男性患者是否安全可行;这些运动模式是否能改善经验证的预后评分与常规护理相比（基于循环生物标志物和临床因素）;与常规护理相比，有监督的有氧运动或阻力运动是否会影响疲劳、身体功能和生活质量;以及抗阻运动对mCRPC男性患者的预后评分和生活质量的影响是否大于有氧运动。这项初步随机对照试验的结果将直接为一项大型、确定性试验的设计提供信息，该试验检查了运动对mCRPC男性患者无病生存期和总生存期的影响。这样的试验将促进mCRPC男性患者运动计划的开发和实施，直接告知临床指南，并改善转移性前列腺癌的临床管理。