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Nutrition Therapy in Improving Immune System in Patients With Bladder Cancer That Can Be Removed by Surgery

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoint revised Secondary endpoints revised (7)v21 Show 1 more changeShow less
    • Secondary endpoints revised (7)

    See this version in full on ClinicalTrials.gov ↗

  2. Results first posted: May 15, 2025 Secondary endpoints: 9 to 7 · Primary endpoint revisedv20 Show 2 more changesShow less
    • Secondary endpoints: 9 to 7
    • Primary endpoint revised

    See this version in full on ClinicalTrials.gov ↗

  3. 2 versions Re-verified since Mar 19, 2024, no change to tracked fieldsv18-v19
  4. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 200 to confirmed 203 · Study sites: 47 to 46 · Primary completion date: Dec 1, 2023 to Jan 1, 2024 · 1 morev17 Show 4 more changesShow less
    • Enrollment target: estimated 200 to confirmed 203
    • Study sites: 47 to 46
    • Primary completion date: Dec 1, 2023 to Jan 1, 2024
    • Completion date: May 1, 2026 to Jan 1, 2027
  5. Start date: Feb 21, 2019 to Mar 5, 2019v16
Show 14 earlier versionsHide 14 earlier versions
  1. Primary completion date: Jul 1, 2023 to Dec 1, 2023v15
  2. Primary completion date: Dec 1, 2023 to Jul 1, 2023 Completion date: Dec 1, 2023 to May 1, 2026v14 Show 1 more changeShow less
    • Completion date: Dec 1, 2023 to May 1, 2026
  3. Trial status: Active, Not Recruiting to Recruiting Study sites: 46 to 47v13 Show 1 more changeShow less
    • Study sites: 46 to 47
  4. Phase: Not applicable to Phase 3 Primary completion date: Jan 1, 2023 to Dec 1, 2023 · Completion date: Aug 1, 2024 to Dec 1, 2023 · Interventions: Laboratory Biomarker Analysis (Other), Nutritional Intervention (Dietary Supplement), Placebo (Other), Quality-of-Life Assessment (Other)… to Laboratory Biomarker Analysis (Other), Nutritional Intervention (Dietary Supplement), Placebo Administration (Other), Quality-of-Life… · 3 morev12 Show 6 more changesShow less
    • Primary completion date: Jan 1, 2023 to Dec 1, 2023
    • Completion date: Aug 1, 2024 to Dec 1, 2023
    • Interventions: Laboratory Biomarker Analysis (Other), Nutritional Intervention (Dietary Supplement), Placebo (Other), Quality-of-Life Assessment (Other)… to Laboratory Biomarker Analysis (Other), Nutritional Intervention (Dietary Supplement), Placebo Administration (Other), Quality-of-Life…
    • Eligibility criteria expanded, about 107 words
    • Secondary endpoints: 8 to 9
    • Study description expanded, about 69 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites revised (46)v11 See this version in full on ClinicalTrials.gov ↗
  6. Study sites: 20 to 46v10
  7. Secondary endpoints: 9 to 8v9 See this version in full on ClinicalTrials.gov ↗
  8. Secondary endpoints revised (9)v8 See this version in full on ClinicalTrials.gov ↗
  9. Primary completion date: Aug 1, 2021 to Jan 1, 2023 Trial status: Recruiting to Active, Not Recruiting · Site details revised at 20 of 20 sitesv7 Show 2 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 20 of 20 sites
  10. Study sites: 16 to 20v6
  11. Study sites: 10 to 16v5
  12. Study sites: 5 to 10v4
  13. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 5 · Primary completion date: Jul 1, 2021 to Aug 1, 2021 · Completion date: Jul 1, 2024 to Aug 1, 2024 · 1 morev3 Show 4 more changesShow less
    • Study sites: 0 to 5
    • Primary completion date: Jul 1, 2021 to Aug 1, 2021
    • Completion date: Jul 1, 2024 to Aug 1, 2024
    • Start date changed from estimate of Feb 15, 2019 to Feb 21, 2019
  14. Start date: Dec 3, 2018 to Feb 15, 2019v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03757949
Lead Sponsor SWOG Cancer Research Network
Collaborators: National Cancer Institute (NCI)
Conditions Bladder Carcinoma
Enrollment 203 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov