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

NCT ID: NCT06733363

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

344 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-15

Study Completion Date

2029-02-28

Brief Summary

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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

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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.

Conditions

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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 Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
The Data Collector will be masked to treatment assignment

Study Groups

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Adaptation

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

Group Type EXPERIMENTAL

Behavioral Dietary Intervention

Intervention Type BEHAVIORAL

Participate in POW-R Health Only/Core program

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

Patients receive study materials and phone calls during life of study

Group Type EXPERIMENTAL

Telephone- Based Intervention

Intervention Type BEHAVIORAL

Receive live phone calls

Interventions

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Behavioral Dietary Intervention

Participate in POW-R Health Only/Core program

Intervention Type BEHAVIORAL

Telephone- Based Intervention

Receive live phone calls

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Roswell Park Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Karen Yeary, MD

Role: CONTACT

Phone: 8772757724

Email: [email protected]

Facility Contacts

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Karen Yeary, MD

Role: primary

Other Identifiers

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R01CA296175

Identifier Type: NIH

Identifier Source: secondary_id

View Link

I-4207024

Identifier Type: -

Identifier Source: org_study_id