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.
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
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)
Parallel
Best Practice
Other interventionReceive SOC
Medical Device Usage and Evaluation
Other interventionWear wearable device
Metformin
DrugGiven PO
Neurocognitive Assessment
Other interventionUndergo neurocognitive test
Questionnaire Administration
Other interventionAncillary studies
Compliance of patients who complete the testing schedule for the cognitive assessments (Feasibility)
Feasibility will be assessed based on compliance of patients to the testing schedule for the cognitive assessments using the Mayo Test Drive tool.
Overall completion rates and compliance (Feasibility)
Will evaluate compliance of completing the patient-reported symptom assessments and the activity and sleep assessments and will assess for any patterns within and between the treatment arms.
Overall satisfaction
Satisfaction/acceptance rates will be evaluated using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C-30, which consists of 30 questions, each answered on a 4-point (e.g., not at all, a little, quite a bit, very much) or a scale of 1-7 where 1=very poor and 7=excellent.
Adherence (Feasibility)
Adherence to study drug will be evaluated in those randomized to the metformin treatment group. Will consider sufficient adherence to be defined as taking at least 80% of the prescribed doses.
Neurocognitive scores
Neurocognitive scores will be assessed using the Mayo Test Drive, a web-based platform for remote self-administered cognitive assessment that uses the Stricker Learning Span (SLS), which is a computer adaptive word-list memory test that matches test difficulty to user performance, and the Symbols test, which is a measure of processing speed and executive functioning that requires timed visual matching. The primary outcome measure will be the Mayo Test Drive raw composite (range 0 - 158). Higher scores indicate better cognitive test performance. Several secondary outcome measures will also be analyzed including but not limited to SLS sum of trials (0-108), an accuracy-weighted Symbols score (0-50), and Symbols average response time for correct items (0+). Participants will have opportunity to provide comments about the testing experience.
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