Nutrition Therapy for Bladder Cancer

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

203 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase III trial studies how well nutrition therapy works in improving immune system in patients with bladder cancer that can be removed by surgery. Improving nutrition before and after surgery may reduce the infections and other problems that sometimes occur after surgery.

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.

What data supports the effectiveness of the treatment Nutrition Therapy for bladder cancer?

Research shows that good nutrition is important for bladder cancer patients undergoing surgery, as malnutrition can lead to more complications and higher risk of death. However, the specific benefits of nutrition therapy for bladder cancer are not clearly established, and more research is needed to confirm its effectiveness. ^{1 2 3 4 5}

Is nutrition therapy safe for bladder cancer patients?

Nutrition therapy, including immune-enhancing supplements, has been studied in bladder cancer patients undergoing surgery. While it may help with returning to a normal diet sooner, there is not enough evidence to confirm its safety or benefits specifically for bladder cancer, and it should be considered investigational. ^{2 5 6 7 8}

How does nutrition therapy differ from other treatments for bladder cancer?

Nutrition therapy for bladder cancer is unique because it focuses on increasing vegetable intake, particularly cruciferous vegetables, to potentially reduce cancer risk, unlike standard treatments that typically involve surgery or chemotherapy. This approach is based on evidence suggesting that high vegetable consumption may lower bladder cancer incidence and mortality. ^{2 3 4 5 6}

Research Team

Jill M Hamilton-Reeves

Principal Investigator

SWOG Cancer Research Network

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Greece pubmed.ncbi.nlm.nih.gov

The Controlling Nutritional Status CONUT Score in Patients With Advanced Bladder Cancer After Radical Cystectomy. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Optimizing Nutritional Status in Patients Undergoing Radical Cystectomy: A Systematic Scoping Review. [2022]

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

The effect of nutritional status and support on morbidity and mortality of bladder cancer patients treated by radical cystectomy. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Prognostic Ability of Nutritional Indices for Outcomes of Bladder Cancer: A Systematic Review and Meta-Analysis. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Malnourishment in bladder cancer and the role of immunonutrition at the time of cystectomy: an overview for urologists. [2018]

6. 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]

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

Complications of radical cystectomy and correlation with nutritional assessment. [2019]

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

Perioperative Immunonutrition Modulates Inflammatory Response after Radical Cystectomy: Results of a Pilot Randomized Controlled Clinical Trial. [2019]