NCT06733363 A Cruciferous Vegetable Eating Program for the Reduction of Cancer Recurrence and Progression in Patients With Non-muscle Invasive Bladder Cancer
| NCT ID | NCT06733363 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Roswell Park Cancer Institute |
| Condition | Non-Muscle Invasive Bladder Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 344 participants |
| Start Date | 2026-01-13 |
| Primary Completion | 2028-01-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 344 participants in total. It began in 2026-01-13 with a primary completion date of 2028-01-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Karen Yeary, MD
PRINCIPAL INVESTIGATOR
Roswell Park Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT06733363 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-Muscle Invasive Bladder Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06733363 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06733363 currently recruiting?
Yes, NCT06733363 is actively recruiting participants. Contact the research team at askroswell@roswellpark.org for enrollment information.
Where is the NCT06733363 trial being conducted?
This trial is being conducted at Buffalo, United States.
Who is sponsoring the NCT06733363 clinical trial?
NCT06733363 is sponsored by Roswell Park Cancer Institute. The principal investigator is Karen Yeary, MD at Roswell Park Comprehensive Cancer Center. The trial plans to enroll 344 participants.