Actively Recruiting
Remote Cognitive Assessment and Wearable Device While Assessing the Impact of Metformin in Patients With History of Cranial Radiation Therapy
Led by Mayo Clinic · Updated on 2025-09-02
100
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Remote Cognitive Assessment and Wearable Device While Assessing the Impact of Metformin in Patients With History of Cranial Radiation Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of brain tumor requiring cranial radiation treatment; enrollment possible during or up to 5 years after cranial radiation for primary or metastatic intracranial tumor
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Karnofsky performance status (KPS) of 70 or higher
- Expected survival of 6 months or more as determined by treatment team
- Willingness and ability to follow the study protocol, including treatment and scheduled visits
- Liver enzyme levels (ALT and AST) at or below 3 times the upper limit of normal, or 5 times for those with baseline liver disease, measured within 30 days prior to registration
- Negative pregnancy test within 8 days prior to registration for persons who can become pregnant
- Ability to complete cognitive assessments and questionnaires independently or with assistance
You will not qualify if you...
- Uncontrolled illness or other condition that limits safety or compliance with the study
- Pregnant or nursing
- Prisoner or lacking capacity to understand the study
- Unable to swallow tablets or at risk for poor absorption of oral medication
- Currently taking metformin and unable to safely stop if assigned to control group
- Known allergy or hypersensitivity to metformin
- Using resveratrol, CoQ10, coconut oil or other medium chain triglyceride supplements, or curcumin and unwilling to stop before and during the study
- Unable to read and speak English as required for the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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