RecruitingPhase 2NCT06377696

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


Sponsor

Mayo Clinic

Enrollment

100 participants

Start Date

May 31, 2024

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether metformin (a common diabetes medication) can help protect the brain from cognitive side effects of radiation therapy in patients who have received cranial radiation for brain tumors, using remote cognitive assessments and wearable devices to track changes. **You may be eligible if...** - You are 18 or older - You have been diagnosed with a brain tumor (primary or metastatic) requiring cranial radiation - You may enroll during radiation or up to 5 years after completing it - Your general health is adequate (ECOG 0–2, Karnofsky 70 or above) - Your expected survival is at least 6 months - Your liver function tests are within acceptable limits **You may NOT be eligible if...** - You have severe kidney disease (which can make metformin unsafe) - You have conditions that would interact badly with metformin - Your health is too poor to safely participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBest Practice

Receive SOC

OTHERMedical Device Usage and Evaluation

Wear wearable device

DRUGMetformin

Given PO

OTHERNeurocognitive Assessment

Undergo neurocognitive test

OTHERQuestionnaire Administration

Ancillary studies


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT06377696


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