Remote Cognitive Assessment and Wearable Device While Assessing the Impact of Metformin in Patients With History of Cranial Radiation Therapy
Neuro-Oncology Anywhere: Deploying Mayo Clinic's Remote Cognitive Assessment Battery and Wearable Device Monitoring Platform While Assessing the Impact of Metformin on Cognition and Quality of Life in Patients With History of Cranial Radiation
Mayo Clinic
100 participants
May 31, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria9
- 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
Exclusion Criteria7
- 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
Interventions
Receive SOC
Wear wearable device
Given PO
Undergo neurocognitive test
Ancillary studies
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06377696