A Problem in NIH and Federally Funded Prostate Cancer Interventional Clinical Trials.

IF 3.2 3区医学 Q2 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH

Journal of Racial and Ethnic Health Disparities Pub Date : 2024-10-01 Epub Date: 2023-08-08 DOI:10.1007/s40615-023-01737-9

Dawood H Sultan, Diana G Ghebrezadik, Desiree S Smith, David N Ombengi, Lolade Ayedun, Faith E Luke, Janee L Demery, Chris T Scoggins, Michelle Penn-Marshall

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引用次数: 0

Abstract

Background: Obesity, diagnosed in 41.1% of African American (AA) men, is a risk factor for prostate cancer (PCa) recurrence, progression, and increased mortality. Obesity is associated with aggressive PCa only in AA men and not White American (WA) men. The overall health of AA PCa patients is also more likely to be adversely affected by comorbid type 2 diabetes (T2D), often an outcome of obesity and a cause of reduced odds of PCa survival. This evidence suggests that preventing and controlling comorbid obesity and T2D in AA men diagnosed with PCa should be a research funding priority.

Aim: The aim of this study is to determine if federally funded PCa clinical trials controlled T2D and obesity.

Methods: Completed interventional PCa clinical trials conducted in the USA, funded by the NIH or other federal agency, which included males aged 18-64 years, and reported study protocols were included in the study. We examined the intervention modalities used in the trials to determine if any attempted to control obesity and T2D.

Results: Fifty-eight trials met the study inclusion criteria. Of these 11 were excluded from the analysis as they did not report AA men. A total of 5802 men participated in the remaining 47 trials. Of these, 917 (15.8%) were AA and 4885 (84.2%) were WA men. Forty (85.1%) trials used pharmaceutical medication therapies or other clinical procedures. None of the medications or clinical procedures used were indicated for treatment of obesity and T2D. 5 (10.6%) trials addressed treatment preferences, survivorship, coping, function, and incontinence among PCa patients. Only 2 (4.25%) trials examined weight loss and diet.

Conclusions: None of the completed federally funded PCa clinical trials that included AA men used methods to control T2D. Only an insignificant number (4.25%) attempted to control obesity. This gap in therapeutic optimization to control these comorbid conditions indicates a critical area in need of federal funding priority.

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美国国立卫生研究院（NIH）和联邦政府资助的前列腺癌介入临床试验中的一个问题。

背景：41.1%的非裔美国人（AA）男性确诊患有肥胖症，肥胖是前列腺癌（PCa）复发、进展和死亡率增加的风险因素。肥胖仅与非裔美国人男性的侵袭性前列腺癌有关，而与美国白人（WA）男性无关。AA PCa 患者的整体健康也更容易受到合并 2 型糖尿病（T2D）的不利影响，而 T2D 通常是肥胖的结果，也是 PCa 存活率降低的原因之一。这些证据表明，预防和控制被诊断为 PCa 的 AA 族男性患者合并肥胖和 T2D 应成为研究资助的优先事项。目的：本研究旨在确定联邦政府资助的 PCa 临床试验是否控制了 T2D 和肥胖：研究纳入了在美国进行的、由美国国立卫生研究院（NIH）或其他联邦机构资助的、纳入 18-64 岁男性的、已完成的 PCa 干预性临床试验，并报告了研究方案。我们检查了试验中使用的干预方式，以确定是否有试验试图控制肥胖和T2D：结果：58 项试验符合研究纳入标准。结果：58 项试验符合研究纳入标准，其中 11 项因未报告男性 AA 而被排除在分析之外。共有 5802 名男性参与了剩余的 47 项试验。其中，917人（15.8%）为AA男性，4885人（84.2%）为WA男性。40项试验（85.1%）采用了药物疗法或其他临床程序。所使用的药物或临床程序都不是用于治疗肥胖症和T2D的。5项（10.6%）试验涉及PCa患者的治疗偏好、生存能力、应对能力、功能和失禁问题。只有2项（4.25%）试验对减肥和饮食进行了研究：结论：在已完成的由联邦政府资助的 PCa 临床试验中，没有一项包括 AA 男性患者的试验采用了控制 T2D 的方法。只有极少数试验（4.25%）试图控制肥胖。在控制这些并发症的治疗优化方面存在的差距表明，这是一个需要联邦政府优先资助的关键领域。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Racial and Ethnic Health Disparities PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH-

CiteScore

7.30

自引率

5.10%

发文量

263

期刊介绍： Journal of Racial and Ethnic Health Disparities reports on the scholarly progress of work to understand, address, and ultimately eliminate health disparities based on race and ethnicity. Efforts to explore underlying causes of health disparities and to describe interventions that have been undertaken to address racial and ethnic health disparities are featured. Promising studies that are ongoing or studies that have longer term data are welcome, as are studies that serve as lessons for best practices in eliminating health disparities. Original research, systematic reviews, and commentaries presenting the state-of-the-art thinking on problems centered on health disparities will be considered for publication. We particularly encourage review articles that generate innovative and testable ideas, and constructive discussions and/or critiques of health disparities.Because the Journal of Racial and Ethnic Health Disparities receives a large number of submissions, about 30% of submissions to the Journal are sent out for full peer review.