Nutrition Therapy for Bladder Cancer

Not currently recruiting at 45 trial locations

Overseen By Jill M. Hamilton-Reeves

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Southwest Oncology Group

Disqualifiers: Pregnancy, HIV, Hepatitis, Galactosemia, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if nutrition therapy can boost the immune system in people undergoing surgery for bladder cancer. The focus is on enhancing nutrition before and after surgery to help reduce infections and other post-surgery complications. Participants will receive either special nutrition supplements or a placebo (a harmless pill with no active ingredients) before and after surgery. This trial suits those diagnosed with surgically removable bladder cancer who do not have severe nutrition issues or certain viral infections. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must have completed any chemotherapy or immunotherapy at least 14 days before joining the trial.

Is there any evidence suggesting that nutrition therapy is likely to be safe for humans?

Research has shown that nutrition therapy can be safe for people with bladder cancer. Studies examining the effects of diet and supplements on cancer outcomes often find positive results without major safety concerns.

One study found that cancer survivors who followed a specific diet consumed more vegetables, suggesting that similar nutrition therapies are well-tolerated. Additionally, certain blood tests related to nutrition can predict cancer outcomes without causing harm.

As this trial is in a later phase, earlier research likely indicates that the treatment is safe enough for broader participation. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for bladder cancer, which typically involve surgery, chemotherapy, and immunotherapy, nutrition therapy offers a unique approach by potentially supporting the body’s natural defenses through dietary supplements. Researchers are particularly excited about this treatment because it focuses on enhancing nutrition before and after surgery, which might improve recovery and outcomes. This method stands out as it aims to complement existing treatments and could provide a non-invasive option that supports overall patient health.

What evidence suggests that nutrition therapy might be an effective treatment for bladder cancer?

This trial will compare the effects of nutrition therapy with a placebo in bladder cancer patients. Research has shown that nutrition therapy can improve outcomes for these patients. Specifically, studies have found that eating raw cruciferous vegetables, such as broccoli, may reduce the risk of cancer recurrence. Additionally, certain diets have effectively boosted beneficial compounds in individuals with bladder cancer. Blood tests related to nutrition might also predict cancer outcomes and support the immune system. Improved nutrition could reduce complications after surgery and aid recovery for bladder cancer patients. ^{1 2 3 5 6}

Who Is on the Research Team?

Jill M Hamilton-Reeves

Principal Investigator

SWOG Cancer Research Network

Are You a Good Fit for This Trial?

This trial is for bladder cancer patients who can undergo surgery, have finished any prior chemotherapy or immunotherapy at least 14 days before, and resolved most side effects. They shouldn't be pregnant, nursing, or planning adjuvant chemotherapy soon after surgery. Participants must not have severe malnutrition or active viral infections like HIV/hepatitis and should be able to swallow liquids.

Inclusion Criteria

Patients must consent and be willing to have specimens collected and submitted

I have had cancer before, but it was either skin cancer, early-stage cancer in remission, or any cancer I've been free from for 2 years.

I can swallow liquids and don't have issues that affect my nutrient absorption.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgery Nutrition

Participants receive specialized immune-modulating drinks or placebo for 5 days before surgery

1 week

Daily intake

Surgery

Participants undergo standard of care radical cystectomy

1 day

In-patient surgery

Post-surgery Nutrition

Participants continue receiving specialized immune-modulating drinks or placebo for 5 days after surgery

1 week

Daily intake

Follow-up

Participants are monitored for post-operative complications and overall health outcomes

36 months

Follow-up visits at 2, 30, and 90 days, and at 6, 9, 12, 18, 24, and 36 months

What Are the Treatments Tested in This Trial?

Interventions

• Nutrition Therapy

Trial Overview The study tests if nutrition therapy improves the immune system in bladder cancer patients around the time of their surgery. It aims to see if better nutrition reduces post-surgery complications. Patients will receive either nutritional intervention or a placebo and complete quality-of-life questionnaires.

How Is the Trial Designed?

Group I: Arm I (SIM) Experimental Treatment 4 Interventions

Patients receive SIM PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.

Group II: Arm II (placebo) Placebo Group 4 Interventions

ARM II: Patients receive placebo PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.

Who Is Running the Clinical Trial?

Southwest Oncology Group

Lead Sponsor

Trials

389

Recruited

260,000+

SWOG Cancer Research Network

Lead Sponsor

Trials

403

Recruited

267,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11325219/

Outcomes of a Dietary Intervention to Reduce Bladder ... A small group of randomized controlled trials (RCTs) have examined the effect of dietary interventions in cancer survivors, with most (>85%) conducted in women ...

2. jnccn.org jnccn.org/abstract/journals/jnccn/22/2/article-e237086.xml

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.

3. kp-scalresearch.org kp-scalresearch.org/eating-raw-vegetables-may-improve-bladder-cancer-outcomes/

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.

4. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2025.1560655/full

Prognostic impact of nutritional indicators based on Lasso ... Current studies showed that blood-based nutritional indicators exhibit robust prognostic predictive ability in cancer outcomes. These biomarkers ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11187017/

Unraveling the Dietary Puzzle: Exploring the Influence of ... Exploring the influence of diet, nutraceuticals, and supplements on bladder cancer risk, outcomes, and immunotherapy efficacy.

6. wcrf.org wcrf.org/wp-content/uploads/2024/10/Bladder-cancer-report.pdf

Diet, nutrition, physical activity and bladder cancer We champion the latest and most authoritative scientific research from around the world on cancer prevention and survival through diet, weight and physical ...