Friday, April 4, 2025
4/4/2025
A scalable cruciferous vegetable intervention to reduce bladder cancer recurrence and progression - Bladder cancer is one of the top 10 cancers in the nation, and the 4th most common cancer in men. The majority (70-80%) of bladder cancer is diagnosed at early stages, known as non-muscle invasive bladder cancer (NMIBC). NMIBC can be removed, yet typically recurs (up to 75%), and some progress with poor prognosis. The majority of patients have no treatment available besides life-long active surveillance, rendering bladder cancer the most expensive cancer to treat. Compelling preclinical and epidemiological evidence show that dietary isothiocyanates (ITCs) from cruciferous vegetables (cruciferae) are particularly potent against bladder cancer given their exclusive excretion to the urine and exposure to the bladder epithelium. Our prospective cohort study also found that high intake of cruciferae, i.e., high ITCs, was associated with delayed bladder cancer recurrence and reduced progression. We translated our bench-side findings to develop a novel, dietary intervention to reduce bladder cancer recurrence and progression in NMIBC patients. Our intervention—POW-R-Health— significantly increased cruciferae intake and urinary ITC levels from baseline to 6 months, achieving urinary ITC levels sufficient to stop or kill at least 50% of bladder cancer cells in in vitro models. However, a considerable literature has documented the diminished effects of behavioral dietary interventions over time. To ensure POW- R Health’s impact on NMIBC outcomes, urinary ITC levels need to be sustained past 6 months because the majority of NMIBC recurrences occur within 24 months post-diagnosis. To sustain urinary ITC levels, we propose to establish the efficacy of POW-R Health with a maintenance component to maintain urinary ITC levels to at least 10 M through a 2-arm randomized controlled trial (RCT). We hypothesize that the POW-R Health + Maintenance arm will result in higher urinary ITC levels maintained compared to the POW-R Health Only arm. Aim 1: Use a systematic process to adapt maintenance strategies from evidence-based dietary interventions to develop an 18-month cruciferae-focused maintenance component for NMIBC survivors. We will expand POW- R Health by adding the adapted maintenance component. Aim 2: Assess the efficacy of POW-R Health + Maintenance compared to POW-R Health Only using a 2-group RCT design in 344 participants with the primary outcome of urinary ITC and the secondary outcome of cruciferae intake. Assessments will occur at baseline, 6, 12, 18, and 24 months. Exploratory Aim 3: Assess the preliminary efficacies of POW-R Health + Maintenance versus POW-R Healthy Only on bladder cancer recurrence and progression at 24 months through medical chart review. Recurrence and progression will be assessed as time to the event at 24 months post enrollment. Urinary proteomics will be conducted on urine samples to provide biological insights on ITC’s effects in the bladder. Our overall goal is to develop a new delivery of care model whereby our intervention can be implemented in healthcare institutions to reduce bladder cancer recurrence and progression for population-level impact on survivorship.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).