Description of a cruciferous vegetable intervention trial to test the efficacy of a maintenance component to reduce bladder cancer recurrence and progression

IF 1.9 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Karen H. Kim Yeary , Margaret Gates Kuliszewski , Han Yu , Qiang Li , Elizabeth DiCarlo , Li Tang
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Abstract

Background

Bladder cancer is primarily (70–80 %) diagnosed at non-muscle invasive stages (NMIBC), which can be removed but typically recurs (up to 75 %) and progresses, necessitating active surveillance and high cost of care. Treatment options are limited. Built on our preclinical findings on the role of isothiocyanates (ITCs) from cruciferous vegetables (cruciferae) in bladder cancer, we developed and tested an intervention (POW-R Health) that increased cruciferae intake and urinary ITC from 6 to 24 months to the levels hypothesized to inhibit cancer growth. To ensure the intervention's impact on NMIBC prognosis, our goal is to sustain urinary ITC levels from baseline to 24 months, the time window when the majority of NMIBCs recur.

Objectives

To develop a maintenance component to our dietary intervention and test its sustained impact on cruciferae intake and urinary ITC levels through 24 months in NMIBC survivors.

Methods

After developing the maintenance component, we will conduct a randomized controlled trial with 344 NMIBC survivors to compare our intervention with a maintenance component (POW-R Health + Maintenance) vs. POW-R Health alone (POW-R Health Core). All participants will receive a 6-month dietary intervention, with half randomized to receive an additional 18-month maintenance component. Assessments will occur at baseline, 6, 12, 18, and 24 months.

Discussion

POW-R Health is a scalable intervention that could meaningfully impact bladder cancer survivorship. If shown to impact outcomes, POW-R Health would be the first non-pharmacological dietary preventative strategy for cancer recurrence and progression, providing a cost-effective and easily accessible intervention to improve NMIBC survivorship.
描述一项十字花科蔬菜干预试验,以测试维持成分减少膀胱癌复发和进展的功效
膀胱癌主要(70 - 80%)诊断为非肌肉浸润期(NMIBC),可以切除,但通常会复发(高达75%)和进展,需要积极监测和高成本的护理。治疗选择是有限的。基于我们对十字花科蔬菜(十字花科)异硫氰酸酯(ITCs)在膀胱癌中的作用的临床前研究结果,我们开发并测试了一种干预措施(POW-R Health),该干预措施将十字花科蔬菜摄入量和尿ITC从6个月增加到24个月,达到抑制癌症生长的假设水平。为了确保干预对NMIBC预后的影响,我们的目标是将尿ITC水平从基线维持到24个月,这是大多数NMIBC复发的时间窗口。目的:为我们的饮食干预开发一种维持成分,并测试其对NMIBC幸存者24个月内十字花科植物摄入量和尿ITC水平的持续影响。在开发维持成分后,我们将对344名NMIBC幸存者进行随机对照试验,以比较我们的干预与维持成分(POW-R健康+维持)和单独的POW-R健康(POW-R健康核心)。所有参与者将接受6个月的饮食干预,其中一半随机接受额外的18个月的维持部分。评估将在基线、6个月、12个月、18个月和24个月进行。pow - r健康是一种可扩展的干预措施,可以对膀胱癌的生存率产生有意义的影响。如果证明对结果有影响,POW-R健康将成为第一个针对癌症复发和进展的非药物饮食预防策略,提供一种成本效益高且易于获得的干预措施,以提高NMIBC的生存率。
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来源期刊
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.
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