Clinical trial NCT06733363: A Cruciferous Vegetable Eating Program for the Reduction of Cancer Recurrence and Progression in Patients With Non-muscle Invasive Bladder Cancer
Official title: A Scalable Cruciferous Vegetable Intervention to Reduce Bladder Cancer Recurrence and Progression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
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
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-12-13
Enrollment: 344
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: 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.

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 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

Primary outcomes:
measure: Urinary isothiocyanates (ITCs) levels
timeFrame: Baseline throughout life of study - up to 24 months
Secondary outcomes:
measure: Increase in Cruciferae Intake
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Comprehensive Cancer Center
state: New York
Study officials:
References: