NCT06733363

A Cruciferous Vegetable Eating Program for the Reduction of Cancer Recurrence and Progression in Patients With Non-muscle Invasive Bladder Cancer

A Scalable Cruciferous Vegetable Intervention to Reduce Bladder Cancer Recurrence and Progression

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 344 (estimated)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Non-Muscle Invasive Bladder Carcinoma
• Recurrent Bladder Carcinoma
• Recurrent Non-Muscle Invasive Bladder Carcinoma
• Stage 0a Bladder Cancer AJCC v8
• Stage 1 Bladder Cancer AJCC v8

Interventions

Type	Name	Description
BEHAVIORAL	Behavioral Dietary Intervention	Participate in POW-R Health Only/Core program
BEHAVIORAL	Telephone- Based Intervention	Receive live phone calls

Timeline

• Start date: 2026-01-13
• Primary completion: 2028-01-13
• Completion: 2029-02-28
• First posted: 2024-12-13
• Last updated: 2026-01-27

Locations

1 site across 1 country: United States