Nutrition Therapy for Bladder Cancer

Recruiting in Palo Alto (17 mi)

+45 other locations

Overseen byJill M Hamilton-Reeves

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Southwest Oncology Group

Pivotal Trial (Near Approval)

Prior Safety Data

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.

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.

+16 more

Participant Groups

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.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm I (SIM)Experimental Treatment4 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 Group4 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.