About this trial
This phase II trial is being done to develop and test a healthy eating program to reduce cancer recurrence (cancer that has come back after a period of improvement) and/or progression (cancer that is growing, spreading, or getting worse) in patients with non-muscle invasive bladder cancer (NMIBC). Researchers want to better understand how incorporating more cruciferous vegetables in the diet may reduce the risk of cancer recurrence or progression in men and women who were diagnosed with early-stage bladder cancer and compare whether extending the program can further improve bladder cancer outcomes. POW-R Health is a behavioral dietary intervention designed to modestly increase cruciferous vegetable (cruciferae) intake in patients. Cruciferous vegetables, such as cabbage, kale and broccoli, arugula, contain phytochemicals known as isothiocyanates (ITCs). Dietary ITCs exert potent anticancer activities against bladder cancer and can be rapidly metabolized, delivered to the bladder, and concentrated in the urine. Participating in the healthy eating program may reduce bladder cancer recurrence or progression in NMIBC survivors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
English speaking
Diagnosed with stage Tis, Ta, or T1 bladder cancer
Age 18 years old or older (no upper limit)
Resides in New York State
Disqualifiers
Participants who had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
Adults unable to consent
Adults unable to complete study measures in English
Individuals who are not yet adults (infants, children, teenagers)
Trial design
Parallel
Treatments tested in this trial
Behavioral Dietary Intervention
BehavioralParticipate in POW-R Health Only/Core program
Telephone- Based Intervention
BehavioralReceive live phone calls
Treatment groups
Trial outcomes
Primary outcomes
Urinary isothiocyanates (ITCs) levels
Levels with be measured using high performance liquid chromatography-based cyclocondensation assay
Secondary outcomes
Increase in Cruciferae Intake
Increase in Cruciferae Intake
Sponsors and contacts
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Roswell Park Cancer Institute
Lead sponsor
National Cancer Institute (NCI)
Collaborator