Remote Cognitive Assessment and Wearable Device While Assessing the Impact of Metformin in Patients With History of Cranial Radiation Therapy

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Best Practice
  • Medical Device Usage and Evaluation
  • Metformin
  • Neurocognitive Assessment
  • Questionnaire Administration

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators