protocolSection identificationModule nctId: NCT06377696, orgStudyIdInfo id: MC230713, secondaryIdInfos id: NCI-2024-02980, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: MC230713, type: OTHER, domain: Mayo Clinic in Rochester, secondaryIdInfos id: 23-005512, type: OTHER, domain: Mayo Clinic Institutional Review Board, briefTitle: Remote Cognitive Assessment Battery and Wearable Device Monitoring Platform While Assessing the Impact of Metformin in Patients With History of Cranial Radiation Therapy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-04-30, completionDateStruct date: 2027-04-30, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Malignant Brain Neoplasm, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Best Practice, interventions name: Medical Device Usage and Evaluation, interventions name: Metformin, interventions name: Neurocognitive Assessment, interventions name: Questionnaire Administration, outcomesModule primaryOutcomes measure: Compliance of patients who complete the testing schedule for the cognitive assessments (Feasibility), secondaryOutcomes measure: Overall completion rates and compliance (Feasibility), secondaryOutcomes measure: Overall satisfaction, secondaryOutcomes measure: Adherence (Feasibility), secondaryOutcomes measure: Neurocognitive scores, secondaryOutcomes measure: Incidence of adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Rochester, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: mayocliniccancerstudies@mayo.edu, contacts name: Ugur T. Sener, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False