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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: askroswell@roswellpark.org
• Phone: 8772757724

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.