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OncoMatch/Clinical Trials/NCT06377696

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

Is NCT06377696 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Metformin for malignant brain neoplasm.

Phase 2RecruitingMayo ClinicNCT06377696Data as of May 2026

Treatment: MetforminThis 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.

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Extracted eligibility criteria

Cancer type

Glioblastoma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Must have received: cranial radiation therapy — for primary or metastatic intracranial tumor

Diagnosis of brain tumor requiring cranial radiation treatment NOTE: Patient may be enrolled during or up to 5 years after completion of cranial radiation administered for treatment of primary or metastatic intracranial tumor

Cannot have received: metformin (metformin)

Exception: cannot safely discontinue if randomized to the control group (Group B)

Currently taking the study agent (i.e., metformin), and cannot safely discontinue if randomized to the control group (Group B)

Lab requirements

Liver function

alt and ast ≤ 3 x uln [≤ 5 x uln for patients with baseline liver disease]

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Mayo Clinic in Rochester · Rochester, Minnesota

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