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Nutrition Therapy for Bladder Cancer

Phase 3
Waitlist Available
Led By Jill M Hamilton-Reeves
Research Sponsored by Southwest Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be able to swallow liquid and have no refractory nausea, vomiting, malabsorption, or significant small bowel resection that would preclude adequate absorption; patients on tube feeding are not eligible
Patients must not be pregnant or nursing as the conditions preclude candidacy for radical cystectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Pivotal Trial

Summary

This trial studies how well nutrition therapy works in improving immune system in patients with bladder cancer that can be removed by surgery.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial focuses on nutrition therapy rather than medication, side effects may include gastrointestinal discomfort from dietary changes. However, specific side effects will depend on individual reactions to the nutritional intervention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can swallow liquids and don't have issues that affect my nutrient absorption.
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I am not pregnant or nursing.
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I finished my chemotherapy or immunotherapy at least 14 days ago and any side effects have mostly gone away.
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I am not scheduled for chemotherapy within 3 months after bladder removal surgery.
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I do not have active HIV or hepatitis infections.
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My nutrition status was checked recently and I am not severely malnourished.
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My surgery will follow specific guidelines approved for this study.
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I do not have galactosemia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Post-operative complications
Secondary study objectives
Anthropometrics and body composition
Complications
Disease free survival
+6 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nutritional Intervention
2011
Completed Phase 3
~690

Find a Location

Who is running the clinical trial?

Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
260,984 Total Patients Enrolled
SWOG Cancer Research NetworkLead Sponsor
398 Previous Clinical Trials
266,399 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,798 Total Patients Enrolled

Media Library

Nutrition Therapy (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03757949 — Phase 3
Bladder Cancer Research Study Groups: Arm I (SIM), Arm II (placebo)
Bladder Cancer Clinical Trial 2023: Nutrition Therapy Highlights & Side Effects. Trial Name: NCT03757949 — Phase 3
Nutrition Therapy (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03757949 — Phase 3
~30 spots leftby Nov 2025
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