Phase 2Active, not recruiting
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 (Academic or other)
- Enrolment
- 100 enrolled
- Conditions
- Malignant Brain Neoplasm
- Interventions
- Best Practice; Medical Device Usage and Evaluation; Metformin; Neurocognitive Assessment; Questionnaire Administration
- Ages
- adults, older adults
- Registry
- NCT06377696
From the registry
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…
Primary outcomes
- Compliance of patients who complete the testing schedule for the cognitive assessments (Feasibility)