Dietary Intervention for Bladder Cancer

KY
Overseen ByKaren Yeary, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Roswell Park Cancer Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a healthy eating program to determine if it can prevent bladder cancer from returning or worsening in individuals with early-stage bladder cancer. Researchers focus on increasing the intake of cruciferous vegetables like cabbage, kale, and broccoli, which are believed to have cancer-fighting properties. The trial will also compare different methods of implementing this Cruciferous Vegetable Eating Program to assess if it leads to better outcomes. This trial is suitable for English-speaking individuals in New York State diagnosed with certain types of early-stage bladder cancer who have not undergone major bladder surgery or recent chemotherapy. As a Phase 2 trial, the research measures how well the treatment works in an initial, smaller group of participants.

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.

Is there any evidence suggesting that this dietary intervention is likely to be safe for humans?

Research has shown that eating raw vegetables like broccoli, which belong to the cruciferous family, may improve outcomes for people with bladder cancer. One study found that those who included these vegetables in their diet were less likely to experience cancer recurrence. Another study linked higher consumption of these vegetables to a reduced risk of developing cancer in general.

These findings suggest that adding cruciferous vegetables to one's diet might be a safe and helpful way to lower cancer risk. The studies reported no negative effects from eating these vegetables, making them a well-tolerated choice for many people.12345

Why are researchers excited about this trial?

Researchers are excited about the Dietary Intervention for Bladder Cancer trial because it explores a unique approach by using a Cruciferous Vegetable Eating Program. Unlike most treatments for bladder cancer, which typically involve surgery, chemotherapy, or immunotherapy, this program focuses on dietary changes to potentially prevent or slow down cancer progression. Cruciferous vegetables, like broccoli and cauliflower, are packed with compounds believed to have anti-cancer properties. This trial aims to uncover if such a natural, non-invasive strategy can be effective, offering a potentially safer and more accessible option compared to traditional treatments.

What evidence suggests that the Cruciferous Vegetable Eating Program might be an effective treatment for bladder cancer?

Research has shown that eating more cruciferous vegetables, like broccoli and cabbage, might help lower the chances of bladder cancer returning or worsening. A study by Kaiser Permanente found that people who ate raw cruciferous vegetables were less likely to experience a recurrence of bladder cancer. Another study found that consuming more of these vegetables increased levels of certain cancer-fighting compounds in the body. However, one study found that simply eating more cruciferous vegetables wasn't strongly linked to a lower risk of bladder cancer. Overall, evidence suggests these vegetables might help reduce the risk of cancer recurrence, but results can vary. Participants in this trial will follow the Cruciferous Vegetable Eating Program to evaluate its impact on bladder cancer outcomes.26789

Who Is on the Research Team?

KY

Karen Yeary, MD

Principal Investigator

Roswell Park Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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
See 3 more

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.
See 3 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Arm II - POW-R Health Only/Core + MaintenanceExperimental Treatment1 Intervention
Group II: AdaptationExperimental Treatment1 Intervention

Find a Clinic Near You

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+

Citations

Cruciferous Vegetable Intervention to Reduce the Risk of ...The aim of this study is to develop a scalable dietary intervention that increases isothiocyanate exposure through Cruciferae intake in NMIBC survivors.
Eating raw vegetables may improve bladder cancer ...Less likely to have their cancer recur if their diet included raw cruciferous vegetables like broccoli, a new Kaiser Permanente study found.
Outcomes of a Dietary Intervention to Reduce Bladder ...To our knowledge, this is the only study that showed an intervention's success in significantly and meaningfully increasing both Cruciferae intake and urinary ...
Dietary consumption of cruciferous vegetables and bladder ...We found that the highest cruciferous vegetables intake was not significantly associated with a lower risk of bladder cancer.
Eating more cruciferous vegetables may be linked to a ...Overall, consuming cruciferous vegetables was associated with a reduced risk of developing cancer, with a 4% lower risk in the cohort studies, ...
Dietary consumption of cruciferous vegetables and bladder ...We found that the highest cruciferous vegetables intake was not significantly associated with a lower risk of bladder cancer.
Outcomes of a Dietary Intervention to Reduce Bladder ...Our dietary intervention is the first to significantly increase Cruciferae intake and urinary ITC levels in NMIBC survivors.
Cruciferous Vegetable Intervention to Reduce the Risk of ...Consumption of raw cruciferous vegetables is inversely associated with bladder cancer risk.
Eating more cruciferous vegetables may be linked to a ...Overall, consuming cruciferous vegetables was associated with a reduced risk of developing cancer, with a 4% lower risk in the cohort studies, ...
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