NCT06377696 Remote Cognitive Assessment and Wearable Device While Assessing the Impact of Metformin in Patients With History of Cranial Radiation Therapy
| NCT ID | NCT06377696 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Mayo Clinic |
| Condition | Malignant Brain Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-05-31 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2024-05-31 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Ugur T. Sener, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic in Rochester
Frequently Asked Questions
Who can join the NCT06377696 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Malignant Brain Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06377696 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06377696 currently recruiting?
Yes, NCT06377696 is actively recruiting participants. Contact the research team at mayocliniccancerstudies@mayo.edu for enrollment information.
Where is the NCT06377696 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT06377696 clinical trial?
NCT06377696 is sponsored by Mayo Clinic. The principal investigator is Ugur T. Sener, MD at Mayo Clinic in Rochester. The trial plans to enroll 100 participants.