Yeary Karen H Kim, Kuliszewski Margaret Gates, Yu Han, Li Qiang, DiCarlo Elizabeth, Tang Li
Roswell Park Comprehensive Cancer Center, Department of Cancer Prevention and Control, Elm and Carlton Streets, Buffalo, NY 14263, USA.
Bureau of Cancer Epidemiology, New York State Department of Health, Albany, NY 12204, USA.
Contemp Clin Trials. 2025 Jul 30;156:108036. doi: 10.1016/j.cct.2025.108036.
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.
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.
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.
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.
膀胱癌主要（70%-80%）在非肌层浸润性阶段（NMIBC）被诊断出来，此时肿瘤可以被切除，但通常会复发（高达75%）并进展，这就需要进行积极监测且护理成本高昂。治疗选择有限。基于我们之前关于十字花科蔬菜中的异硫氰酸盐（ITCs）在膀胱癌中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），该措施在6至24个月内将十字花科蔬菜的摄入量和尿ITC提高到假设可抑制癌症生长的水平。为确保该干预措施对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。
为我们的饮食干预开发一个维持部分，并在NMIBC幸存者中测试其在24个月内对十字花科蔬菜摄入量和尿ITC水平的持续影响。
在开发出维持部分后，我们将对344名NMIBC幸存者进行一项随机对照试验，以比较我们的干预措施（POW-R Health + 维持）与仅POW-R Health（POW-R Health核心组）。所有参与者将接受为期6个月的饮食干预，其中一半随机分配接受额外的18个月维持部分。评估将在基线、6、12、18和24个月时进行。
POW-R Health是一种可扩展的干预措施，可能对膀胱癌幸存者产生重大影响。如果证明对结果有影响，POW-R Health将成为首个针对癌症复发和进展的非药物饮食预防策略，提供一种经济有效且易于获得的干预措施来改善NMIBC幸存者的状况。
