运动增强黑人前列腺癌患者雄激素剥夺治疗（POWER试验）的心血管健康：一项研究方案。

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-05-30 DOI:10.1016/j.cct.2025.107973

Dong-Woo Kang , Salvatore Ficarra , Rebekah L. Wilson , Alicia K. Morgans , Paul L. Nguyen , Timothy R. Rebbeck , David J. Einstein , Hajime Uno , Matthew Mossanen , Danielle M. Hill , Paola Gonzalo-Encabo , Mary K. Norris , John Gardiner , Darryl Tjogas , Jocelyn Greer , Christina M. Dieli-Conwright

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引用次数: 0

摘要

背景：美国黑人男性患前列腺癌和死于前列腺癌的可能性分别是非西班牙裔白人男性的1.8倍和2.2倍，是全球发病率最高的。此外，与其他种族的男性相比，接受雄激素剥夺疗法（ADT）治疗前列腺癌的黑人男性患心血管疾病（CVD）的风险更高。因此，我们设计了一项随机对照试验（RCT）来研究运动对接受ADT的黑人心血管疾病危险因素的影响。方法：POWER试验是一项双臂随机对照试验，旨在检查16周、文化定制、远程监督心血管和力量锻炼计划对接受ADT的黑人前列腺癌患者的影响。62名患者将以1:1的比例随机分配到运动干预组或候补对照组。患者人群包括自我认同为黑人的成年男性，在招募时接受ADT至少四个月。主要结果是使用Framingham风险评分评估心血管疾病风险。次要和探索性结果包括身体健康和功能、患者报告的结果和一年随访的临床事件。讨论：POWER试验评估了针对接受ADT的黑人前列腺癌患者的文化量身定制的锻炼计划，重点是改善心血管健康。该研究的结果有望为更大规模的临床试验提供信息，以检查与心血管疾病相关的长期临床结果。最终，我们的发现和随后的试验将缩小患有前列腺癌的黑人男性社区之间的健康差距。试验注册：NCT05327465。

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Exercise to enhance cardiovascular health among black men with prostate cancer with androgen deprivation therapy (the POWER trial): A study protocol

Background

Black men in the US are 1.8 and 2.2 times more likely to develop and die from prostate cancer (PCa) than non-Hispanic White men, respectively, and have the highest incidence globally. Furthermore, Black men undergoing androgen deprivation therapy (ADT) for PCa face a higher risk of cardiovascular disease (CVD) compared to men of other racial groups. Therefore, we have designed a randomized controlled trial (RCT) to investigate the impact of exercise on CVD risk factors among Black man undergoing ADT.

Methods

The POWER trial is a dual-arm RCT designed to examine the effects of a 16-week, culturally tailored, remotely supervised cardiovascular and strength exercise program on Black men with PCa receiving ADT. Sixty-two patients will be randomized in a 1:1 allocation to either the exercise intervention or a waitlist control group. The patient population includes adult males who self-identify as Black, receiving ADT for at least four months prospectively at the time of recruitment. The primary outcome is the CVD risk assessed using the Framingham Risk Score. The secondary and exploratory outcomes include physical fitness and function, patient-reported outcomes, and clinical events at a one-year follow-up.

Discussion

The POWER Trial evaluates a culturally tailored exercise program for Black men with PCa undergoing ADT, focusing on improving cardiovascular health. The findings of the study are expected to inform a larger phase clinical trial to examine long-term CVD-related clinical outcomes. Ultimately, our findings and subsequent trials would narrow the gap in health disparities among the communities of Black men with PCa.

Trial registration: NCT05327465

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.