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Metformin for the Prevention of Oral Cancer in Patients With Oral Leukoplakia or Erythroplakia

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Notable Results posted: Sep 2, 2026 Show 4 more changesShow less
    • Secondary endpoints: details revised at 5 of 6 entries
    • Site details revised at 2 of 10 sites
    • Publications: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 5 words
  2. Notable Results first posted: Sep 2, 2026
    • Secondary endpoints: 4 to 6
    • Primary endpoint revised
    v22
  3. Minor Primary completion date changed from estimate of Dec 31, 2025 to Nov 7, 2025v21
  4. Minor Primary completion date: Aug 31, 2026 to Dec 31, 2025
    • Study completion date: Aug 31, 2028 to Dec 2026
    v20
  5. Minor Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 86 to confirmed 34
    • Site details revised at 10 of 10 sites
    v19
Show 17 earlier versionsHide 17 earlier versions
  1. Minor Eligibility criteria revisedv18
  2. Minor Site contacts updated at 10 of 10 sitesv17
  3. Notable Start date: Nov 28, 2022 to Jan 12, 2023
    • Primary completion date: Jul 31, 2026 to Aug 31, 2026
    • Study completion date: Jul 31, 2026 to Aug 31, 2028
    v16
  4. Minor Re-verified, no change to tracked fieldsv15
  5. Minor Site contacts updated at 1 of 10 sitesv14
  6. Notable Lead sponsor: National Cancer Institute (NCI) to University of Arizona
    • Collaborators expanded, about 4 words
    v13
  7. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 27, 2023 to Nov 28, 2022
    • Site details revised at 10 of 10 sites
    v12
  8. Minor 2 versions Re-verified since Dec 14, 2022, no change to tracked fieldsv10-v11
  9. Notable Start date: Mar 25, 2023 to May 27, 2023
    • Primary and study completion dates: May 31, 2026 to Jul 31, 2026
    • Eligibility criteria expanded, about 161 words
    • Study description expanded, about 24 words
    v9
  10. Minor Re-verified, no change to tracked fieldsv8
  11. Notable Start date: Sep 30, 2022 to Mar 25, 2023
    • Primary and study completion dates: Mar 31, 2026 to May 31, 2026
    • Interventions: Extended Release Metformin Hydrochloride (Drug), Placebo Administration (Drug) to Biopsy (Procedure), Biospecimen Collection (Procedure), Extended Release Metformin Hydrochloride (Drug), Placebo Administration (Drug)
    • Eligibility criteria expanded, about 51 words
    v7
  12. Minor Re-verified, no change to tracked fieldsv6
  13. Notable Start date: Jul 19, 2022 to Sep 30, 2022v5
  14. Minor Study sites revised (10)v4
  15. Minor 2 versions Re-verified since Jun 7, 2022, no change to tracked fieldsv2-v3
  1. Minor 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 IIb trial tests whether metformin works in preventing oral cancer in patients with oral leukoplakia (white patches) or erythroplakia (red patches). Metformin is in a class of drugs called biguanides. Metformin helps to control the amount of glucose (sugar) in the blood. It decreases the amount of glucose patients absorb from food and the amount of glucose made by the liver. Metformin also increases the body's response to insulin, a natural substance that controls the amount of glucose in the blood. This trial may help researchers determine if metformin can stop changes in the mouth that are related to pre-cancer growths in the mouth.
Trial Details
NCT Number NCT05237960
Lead Sponsor University of Arizona
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)
Erythroplakia, Oral Leukoplakia
Related terms Erythroplasia, Leukoplakia, Oral
Enrollment 34 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov