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

NCT06733363 | Recruiting Phase 2

• 2 other identifiers: I-4207024R01CA296175
• Study Type: interventional
• Target: 344
• Locations: 1 country
• Sites: 1

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

Recurrent Bladder Carcinoma; Recurrent Non-Muscle Invasive Bladder Carcinoma; Stage 0a Bladder Cancer AJCC v8; Stage 1 Bladder Cancer AJCC v8; Non-Muscle Invasive Bladder Carcinoma

Outcome Measures

Primary Outcomes (1)

• Urinary isothiocyanates (ITCs) levels

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

  Baseline throughout life of study - up to 24 months

Secondary Outcomes (1)

• Increase in Cruciferae Intake

  up to 24 months

Study Arms (2)

Adaptation

EXPERIMENTAL

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

Behavioral: Behavioral Dietary Intervention

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

EXPERIMENTAL

Patients receive study materials and phone calls during life of study

Behavioral: Telephone- Based Intervention

Interventions

Behavioral Dietary Intervention BEHAVIORAL

Participate in POW-R Health Only/Core program

Adaptation

Telephone- Based Intervention BEHAVIORAL

Receive live phone calls

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

RECRUITING

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms; Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Karen Yeary, MD

  Roswell Park Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Yeary, MD

CONTACT

8772757724; askroswell@roswellpark.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The Data Collector will be masked to treatment assignment
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start: January 13, 2026
• Primary Completion (Estimated): January 13, 2028
• Study Completion (Estimated): February 28, 2029
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

US (1)