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

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.

Study Overview

• Status: Recruiting
• Conditions: Recurrent Bladder Carcinoma; Stage 0a Bladder Cancer AJCC v8; Recurrent Non-Muscle Invasive Bladder Carcinoma; Non-Muscle Invasive Bladder Carcinoma; Stage 1 Bladder Cancer AJCC v8
• Intervention / Treatment: Behavioral: Behavioral Dietary Intervention; Behavioral: Telephone- Based Intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 344
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Karen Yeary, MD; Phone Number: 8772757724; Email: askroswell@roswellpark.org

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Recruiting
      • Roswell Park Comprehensive Cancer Center
      • Contact: Karen Yeary, MD; Phone Number: 877-275-7724; Email: askroswell@roswellpark.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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)
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Unwilling or unable to follow protocol requirements

  • The following special populations ae excluded from this study:

    • Cognitively impaired adults/adults with impaired decision-making capacity
    • Individuals who are not yet adults (infants, children, teenagers)
    • Pregnant women
    • Prisoners

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adaptation; CAB members participate in maintenance phase development discussion over an hour up to 3 times per week.	Behavioral: Behavioral Dietary Intervention; Participate in POW-R Health Only/Core program
Experimental: Arm II - POW-R Health Only/Core + Maintenance; Patients receive study materials and phone calls during life of study	Behavioral: Telephone- Based Intervention; Receive live phone calls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary isothiocyanates (ITCs) levels	Levels with be measured using high performance liquid chromatography-based cyclocondensation assay	Baseline throughout life of study - up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increase in Cruciferae Intake	Increase in Cruciferae Intake	up to 24 months

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Karen Yeary, MD, Roswell Park Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2026
• Primary Completion (Estimated): January 13, 2028
• Study Completion (Estimated): February 28, 2029

Study Registration Dates

• First Submitted: December 10, 2024
• First Submitted That Met QC Criteria: December 10, 2024
• First Posted (Actual): December 13, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Urologic Neoplasms; Carcinoma; Urinary Bladder Diseases; Non-Muscle Invasive Bladder Neoplasms; Urinary Bladder Neoplasms
• Other Study ID Numbers: I-4207024; R01CA296175 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes