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NCT Number: NCT06733363

A Cruciferous Vegetable Eating Program for the Reduction of Cancer Recurrence and Progression in Patients With Non-muscle Invasive Bladder Cancer

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.

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Key information

Conditions

Non-Muscle Invasive Bladder Carcinoma Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-Muscle Invasive Bladder Neoplasms Recurrent Bladder Carcinoma Recurrent Non-Muscle Invasive Bladder Carcinoma Stage 0a Bladder Cancer AJCC v8 Stage 1 Bladder Cancer AJCC v8 Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

Location status: Recruiting

Location contact

Karen Yeary, MD

CONTACT

[email protected]

877-275-7724

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

behavioral dietary intervention

Behavioral

Participate in POW-R Health Only/Core program

Telephone- Based Intervention

Behavioral

Receive live phone calls

Primary outcomes

  1. Urinary isothiocyanates (ITCs) levels

    Time frame: Baseline throughout life of study - up to 24 months

    Levels with be measured using high performance liquid chromatography-based cyclocondensation assay

Secondary outcomes

  1. Increase in Cruciferae Intake

    Time frame: up to 24 months

    Increase in Cruciferae Intake

Study contacts

Contact information is provided by the study sponsor or research team.

Karen Yeary, MD

CONTACT

[email protected]

8772757724

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Dec 13, 2024
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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