Dietary Intervention for Bladder Cancer

Overseen By Karen Yeary, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Roswell Park Cancer Institute

Disqualifiers: Chemotherapy, Radiotherapy, Uncontrolled illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

344 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does exclude participants who had chemotherapy or radiotherapy within 4-6 weeks before the study, so it's best to discuss your specific medications with the trial coordinators.

What data supports the effectiveness of the treatment Cruciferous Vegetable Eating Program for bladder cancer?

Research suggests that eating cruciferous vegetables, which contain compounds called isothiocyanates, may help reduce the risk of bladder cancer and improve survival rates. Studies have shown that these vegetables can have protective effects against bladder cancer, especially when consumed raw. ^{1 2 3 4 5}

Is the Cruciferous Vegetable Eating Program safe for humans?

Research suggests that increasing intake of cruciferous vegetables, like broccoli, is generally safe for humans and may even help reduce the risk of bladder cancer. These vegetables contain compounds that have been studied for their potential health benefits, and no significant safety concerns have been reported in the studies reviewed. ^{1 3 4 5 6}

How does the Cruciferous Vegetable Eating Program treatment differ from other bladder cancer treatments?

The Cruciferous Vegetable Eating Program is unique because it uses a dietary approach to increase the intake of cruciferous vegetables, which contain isothiocyanates that may help prevent bladder cancer recurrence and progression. Unlike traditional treatments, this program is noninvasive, cost-effective, and focuses on the chemoprotective properties of natural food components. ^{1 2 4 5 7}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for men and women diagnosed with non-muscle invasive bladder cancer (NMIBC) who are interested in a dietary program to potentially reduce the risk of their cancer coming back or getting worse. Specific eligibility criteria details were not provided.

Inclusion Criteria

Cancer not reported by a lab, nursing home, or death certificate/autopsy only

I have not had surgery to remove my bladder.

English speaking

Exclusion Criteria

Unwilling or unable to follow protocol requirements

I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

I am not pregnant, imprisoned, or have cognitive impairments affecting my decision-making.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the POW-R Health intervention to increase cruciferous vegetable intake

24 months

Regular phone calls and study material distribution

Follow-up

Participants are monitored for urinary isothiocyanates (ITCs) levels and cruciferae intake

4 weeks

Treatment Details

Interventions

• Cruciferous Vegetable Eating Program

Trial Overview The study tests a healthy eating program called POW-R Health, focusing on increasing intake of cruciferous vegetables like cabbage, kale, broccoli, and arugula to see if they can help prevent bladder cancer from returning or progressing.

Participant Groups

Group I: Arm II - POW-R Health Only/Core + Maintenance Experimental Treatment 1 Intervention

Patients receive study materials and phone calls during life of study

Group II: Adaptation Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

A randomized pilot trial of dietary modification for the chemoprevention of noninvasive bladder cancer: the dietary intervention in bladder cancer study. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Intake of cruciferous vegetables modifies bladder cancer survival. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Consumption of cruciferous vegetables and the risk of bladder cancer in a prospective US cohort: data from the NIH-AARP diet and health study. [2021]

4. Canada pubmed.ncbi.nlm.nih.gov

Cruciferous Vegetable Intervention to Reduce the Risk of Cancer Recurrence in Non-Muscle-Invasive Bladder Cancer Survivors: Development Using a Systematic Process. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Consumption of raw cruciferous vegetables is inversely associated with bladder cancer risk. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Cruciferous Vegetables, Isothiocyanates, and Bladder Cancer Prevention. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Mechanistic review of sulforaphane as a chemoprotective agent in bladder cancer. [2023]