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

Recruiting now · Phase 2

Conditions studied: Malignant Brain Neoplasm

In brief

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.

Key facts

Study ID: NCT06377696
Run by: Mayo Clinic
People needed: 100
Starts: 2024-05-31
Expected to finish: 2027-05-01
Last updated by the study team: 2026-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age ≥ 18 years
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
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, AND Karnofsky performance status (KPS) of ≥ 70
Expected survival ≥ 6 months in the opinion of treatment team
Willing and able to adhere with the protocol for the duration of the study including undergoing treatment, and attending scheduled visits, and examinations
The following laboratory values obtained ≤ 30 days prior to registration:
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN [≤ 5 x upper limit normal (ULN) for patients with baseline liver disease]
Negative pregnancy test ≤ 8 days prior to registration for persons of childbearing potential only
Ability to complete cognitive assessments and questionnaires by themselves or with assistance

You may not qualify if…

Uncontrolled and/or intercurrent illness or other condition which limits safety of or compliance with study proceedings
Pregnant or nursing, imprisoned, or lacking capacity for understanding
Unable to swallow tablets or at risk for impaired absorption of oral medication
Currently taking the study agent (i.e., metformin), and cannot safely discontinue if randomized to the control group (Group B)
Known hypersensitivity or allergy to metformin
Current use of resveratrol, CoQ10 (coenzyme Q10), coconut oil/other medium chain triglyceride-containing (e.g., Axona) supplements, or curcumin and unwilling to discontinue prior to registration and remain off these agents for study duration
Unable to read and speak English. Note: English doses not to need to be primary language

Where it is running

Mayo Clinic in Rochester — Rochester, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

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