Recruiting
Phase 2

Healthy Eating Program

Sponsor:

Roswell Park Cancer Institute

Code:

NCT06733363

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Behavioral Dietary Intervention

Telephone- Based Intervention

Study Details

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.

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

Study ID

NCT06733363

Start date

Jan 13, 2026

Status verified date

May, 2026

Completion date

Feb 28, 2029

Anticipated

Primary completion date

Jan 13, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

344 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Adaptation

CAB members participate in maintenance phase development discussion over an hour up to 3 times per week.

experimental: Arm II - POW-R Health Only/Core + Maintenance

Patients receive study materials and phone calls during life of study

Interventions

Behavioral Dietary Intervention

Participate in POW-R Health Only/Core program

Telephone- Based Intervention

Receive live phone calls

Primary outcome measure

  • Urinary isothiocyanates (ITCs) levels [ Time Frame: Baseline throughout life of study - up to 24 months ]

Central Contacts and Locations

Central contacts

Karen Yeary, MD

8772757724askroswell@roswellpark.org

Locations

Roswell Park Comprehensive Cancer Center

Recruiting

Buffalo, New York, United States, 14263

Contacts

Karen Yeary, MD

877-275-7724askroswell@roswellpark.org

More Information

Sponsor

Roswell Park Cancer Institute

Last update posted

May 8, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Roswell Park Cancer Institute on 2026-05-08.