A randomized pilot trial of dietary modification for the chemoprevention of noninvasive bladder cancer: the dietary intervention in bladder cancer study.

Epidemiological data suggest robust associations of high vegetable intake with decreased risks of bladder cancer incidence and mortality, but translational prevention studies have yet to be conducted. We designed and tested a novel intervention to increase vegetable intake in patients with noninvasive bladder cancer. We randomized 48 patients aged 50 to 80 years with biopsy-proven noninvasive (Ta, T1, or carcinoma in situ) urothelial cell carcinoma to telephone- and Skype-based dietary counseling or a control condition that provided print materials only. The intervention behavioral goals promoted seven daily vegetable servings, with at least two of these as cruciferous vegetables. Outcome variables were self-reported diet and plasma carotenoid and 24-hour urinary isothiocyanate (ITC) concentrations. We used two-sample t tests to assess between-group differences at 6-month follow-up. After 6 months, intervention patients had higher daily intakes of vegetable juice (P = 0.02), total vegetables (P = 0.02), and cruciferous vegetables (P = 0.07); lower daily intakes of energy (P = 0.007), fat (P = 0.002) and energy from fat (P = 0.06); and higher plasma α-carotene concentrations (P = 0.03). Self-reported cruciferous vegetable intake correlated with urinary ITC concentrations at baseline (P < 0.001) and at 6 months (P = 0.03). Although urinary ITC concentrations increased in the intervention group and decreased in the control group, these changes did not attain between-group significance (P = 0.32). In patients with noninvasive bladder cancer, our novel intervention induced diet changes associated with protective effects against bladder cancer. These data show the feasibility of implementing therapeutic dietary modifications to prevent recurrent and progressive bladder cancer.

RCT Entities:   Population Interventions Outcomes