A Scalable Cruciferous Vegetable Intervention to Reduce Bladder Cancer Recurrence and Progression
Roswell Park Cancer Institute
Summary
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.
Description
PRIMARY OBJECTIVES: I. Develop a maintenance component to add onto our POW-R Health intervention (POW-R Health Only/Core) to create POW-R Health + Maintenance. II. Assess the efficacy of POW-R Health + Maintenance compared to POW-R Health Only/Core using a 2-group randomized controlled trial (RCT) design in 344 participants on the primary outcome of urinary ITC. SECONDARY OBJECTIVE: I. Assess the efficacy of POW-R Health + Maintenance compared to POW-R Health Only/Core on the secondary outcome of cruciferae intake.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Cancer not reported by a lab, nursing home, or death certificate/autopsy only * Did not receive a partial or radical cystectomy * Does not have other cancer diagnosis within 12 month of bladder cancer diagnosis except for cancers deemed low risk and unlikely to impact study participation (e.g., basal cell carcinoma, nor under active treatment for any other cancers Exclusion Criteria: * Participants who had chemoth…
Interventions
- BehavioralBehavioral Dietary Intervention
Participate in POW-R Health Only/Core program
- BehavioralTelephone- Based Intervention
Receive live phone calls
Location
- Roswell Park Comprehensive Cancer CenterBuffalo, New York