||1R21CA253910-01 Interpret this number
||Roswell Park Cancer Institute Corp
||A Pragmatic Dietary Intervention to Improve Bladder Cancer Survivorship
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 an early stage, when the cancer is confined to the
epithelial and lamina propria layer of the bladder and known as non-muscle invasive bladder cancer (NMIBC).
NMIBC can be removed successfully; however, 50-80% of NMIBC recurs within 5 years, with some patients
experiencing multiple recurrences at similar stages. Clinical management requires life-long surveillance by
cystoscopy for NMIBC patients, amounting to bladder cancer being the most expensive cancer to treat. Novel
and cost-effective intervention strategies to control NMIBC recurrence and progression are urgently needed.
Our findings from in vitro, in vivo, and epidemiologic studies support that dietary isothiocyanates (ITCs) exert
potent anti-cancer activities against bladder cancer. ITCs are a group of phytochemicals primarily derived from
cruciferous vegetables and oral consumption of dietary ITCs can be rapidly metabolized, delivered to the
bladder and concentrated in the urine, rendering the abnormal bladder epithelium the best target. In our
retrospective study, high consumption of raw cruciferous vegetables was associated with reduced bladder
cancer-specific mortality and overall mortality. We propose to translate our strong preclinical findings into a
novel, dietary behavioral intervention to reduce bladder cancer recurrence and progression in NMIBC patients.
We will partner with the New York State Cancer Registry to recruit eligible patients and their clinical care
providers in our catchment area, which has a disproportionally high burden of bladder cancer. Specific Aim 1:
Develop an evidence-based behavioral intervention to increase cruciferous vegetable intake, with the goal of
attaining desirable urinary ITC levels effective for anti-cancer activities. We will work with our Community
Advisory Board to adapt materials and methods from current evidence-based fruit and vegetable interventions
and leverage our findings on ITC yield from cruciferous vegetables to develop our dietary intervention, using a
systematic process consisting of information gathering, discussion groups, and mock intervention delivery.
Specific Aim 2: Conduct a feasibility pilot of our dietary behavioral intervention through a hybrid I
implementation randomized controlled design in 80 NMIBC survivors, where the treatment group (n=40) will
receive an evidence-based telephone intervention to increase cruciferous vegetable intake and the control
group (n=40) will receive a general fruit and vegetable intake intervention based on NCI guidelines. Primary
outcomes will be cruciferous vegetable intake and urinary ITC levels, and the secondary outcome will be gene
expression changes in urinary exfoliated epithelial cells as a surrogate for intermediate efficacy. Exploratory
Aim: Engage the clinical care providers of patients enrolled in our intervention to ascertain the barriers and
facilitators of intervention implementation within clinical practice through conducting 20 semi-structured
interviews. The goal is to gain feedback and refine the intervention for “real-world' implementation.
Cruciferous Vegetable Intervention to Reduce the Risk of Cancer Recurrence in Non-Muscle-Invasive Bladder Cancer Survivors: Development Using a Systematic Process.
, Clark N.
, Saad-Harfouche F.
, Erwin D.
, Kuliszewski M.G.
, Li Q.
, McCann S.E.
, Yu H.
, Lincourt C.
, Zoellner J.
, et al.
JMIR cancer, 2022-02-15; 8(1), p. e32291.