At a glance
ClinicalIndex Comparison RecordPhase 3Active· 203 enrolled
Drug / intervention
Laboratory Biomarker Analysis +4 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Phase III Double Blind Clinical Trial Evaluating the Effect of Immune-Enhancing Nutrition on Radical Cystectomy Outcomes
In Brief
A Phase 3 clinical trial evaluating Laboratory Biomarker Analysis, Nutritional Intervention, and 3 other interventions for Bladder Carcinoma. Active but no longer recruiting, targeting 203 participants across 46 sites.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBladder Carcinoma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 3Active
201920202021202220232024202520262027
First PostedNov 2018
Enrollment StartMar 2019
Primary CompletionJan 2024
TodayJul 2026
Study CompletionJan 2027
First PostedNov 29, 2018
Enrollment StartMar 5, 2019
Primary CompletionJan 1, 2024
Study CompletionJan 1, 2027
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 7.6 years ago
Interventions
Laboratory Biomarker Analysisother
Correlative studies
Nutritional Interventiondietary
Receive SIM PO
Placebo Administrationother
Given PO
Quality-of-Life Assessmentother
Ancillary studies
Questionnaire Administrationother
Ancillary studies