Cruciferous vegetable eating program to reduce recurrence and progression in early-stage bladder cancer

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

This trial will test whether a behavioral program that increases cruciferous vegetable intake (like broccoli, cabbage, kale) and a maintenance component can lower recurrence or progression in adults with early-stage non-muscle invasive bladder cancer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 344 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Roswell Park Cancer Institute (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Buffalo, New York)
• Trial ID: NCT06733363 on ClinicalTrials.gov

What this trial studies

This Phase II randomized trial at Roswell Park will enroll 344 adults with stage Tis, Ta, or T1 non‑muscle invasive bladder cancer and randomize them to the POW-R Health core dietary intervention alone or POW-R Health with an added maintenance component. The intervention is behavioral and telephone‑based and is designed to modestly increase intake of cruciferous vegetables that contain isothiocyanates (ITCs). The primary outcome is urinary ITC levels as a biomarker of exposure, and a key secondary outcome is self-reported cruciferae intake. The trial compares the two intervention arms to see if adding maintenance improves sustained intake and bladder-related biomarker levels.

Who should consider this trial

Good fit: Adults (18+) who speak English, live in New York State, have a diagnosis of stage Tis, Ta, or T1 non‑muscle invasive bladder cancer, have not had a partial or radical cystectomy, and have not had recent chemotherapy or radiotherapy within the specified washout periods are ideal candidates.

Not a fit: Patients with muscle‑invasive disease, recent active chemotherapy or radiotherapy without recovery, those living outside New York State, non‑English speakers, or people who have had a cystectomy are unlikely to benefit from this program.

Why it matters

Potential benefit: If successful, the program could lower the risk of bladder cancer coming back or getting worse by helping patients sustain higher intake of cruciferous vegetables that deliver anticancer compounds to the bladder.

How similar studies have performed: Laboratory and observational studies support anticancer activity of dietary isothiocyanates in bladder tissue, but randomized trials testing a behavioral cruciferous‑vegetable intervention with a maintenance component are limited, making this approach relatively novel in clinical testing.

Eligibility criteria

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

Where this trial is running

Buffalo, New York

• Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Karen Yeary, MD — Roswell Park Comprehensive Cancer Center
• Study coordinator: Karen Yeary, MD

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