Remote Cognitive Assessment and Wearable Device While Assessing the Impact of Metformin in Patients With History of Cranial Radiation Therapy

StatusActive, Not Recruiting
PhasePhase 2
Started

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Record History

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  1. Minor Enrollment closed, study ongoing Show 6 more changesShow less
    • Primary completion moved earlier from May 1, 2027 to Feb 1, 2027
    • Study completion pushed from May 1, 2027 to Feb 1, 2028
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 3 of 5 entries
    • Site details revised
    • Publications: details revised at 1 of 1 entry
  2. Minor 2 versions Re-verified since Aug 29, 2025, no change to tracked fieldsv9-v10
  3. Minor Site contact updatedv8
  4. Minor Eligibility criteria revised
    • Site contact updated
    v7
  5. Minor Primary and study completion dates: May 2027 to May 1, 2027
    • Site contact updated
    • Study title shortened, about 3 words
    v6
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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v5
  2. Notable Start date: May 1, 2024 to May 31, 2024
    • Primary and study completion dates: Apr 30, 2027 to May 2027
    v4
  3. Minor Secondary endpoints: details revised at 2 of 5 entriesv3
  4. Minor Secondary endpoints: details revised at 1 of 5 entriesv2
  1. Minor Study First Submitted
  • 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.
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This phase III trial evaluates whether patient care can be done remotely for patients having cranial (skull) radiation or who have previously had cranial radiation. In addition, this trial compares study outcomes between patients who get metformin and those who do not. Cranial radiation, an essential component of brain tumor treatment, can result in significant negative effects on cognitive (the ability to clearly think, learn, and remember) function. Wearable devices have been used in the field of neurology for seizure detection and assessment of patients with movement disorders. Wearable device technology has also been implemented for remote monitoring of cancer patients and for cancer clinical trials. Metformin is the active ingredient in a drug used to treat type 2 diabetes mellitus (a condition in which the body cannot control the level of sugar in the blood). It is also being studied in the treatment of cancer. Use of metformin may reduce risk of cognitive decline following radiation therapy within the skull (intracranial). These effects may be further strengthen by addition of device-based physical activity promotion. Mayo Test Drive is a web-based platform for remote self-administered cognitive assessment. Using Mayo Test Drive may help determine whether patient care can be done remotely, while simultaneously evaluating benefits of health promotion through use of a wearable watch device and metformin in preventing radiation-related cognitive decline.
Trial Details
NCT Number NCT06377696
Lead Sponsor Mayo Clinic
Conditions
(from sponsor)
Malignant Brain Neoplasm
Related terms Brain Neoplasms
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov