Remote cognitive assessment and wearable device use in patients with brain tumors receiving metformin
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
This study is testing if metformin can help improve thinking, activity, and sleep in patients with brain tumors who have had radiation therapy, while also using wearable devices to track their progress.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06377696 on ClinicalTrials.gov |
What this trial studies
This phase II trial evaluates the feasibility of conducting remote cognitive assessments for patients who have undergone cranial radiation therapy. It compares outcomes between those receiving metformin and those who do not, focusing on cognitive function, activity, and sleep data. Participants will be randomized into two groups: one receiving metformin and the other receiving standard care with wearable device monitoring. The study aims to assess patient satisfaction, compliance, and the safety of metformin in this population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of brain tumor requiring cranial radiation treatment.
Not a fit: Patients who have not undergone cranial radiation therapy or those with a poor prognosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve cognitive outcomes and quality of life for patients who have undergone cranial radiation therapy.
How similar studies have performed: Other studies have shown promise in using remote monitoring and metformin for cognitive health, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Ugur T. Sener, MD — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.