Recruiting
Phase 2

Metformin

Sponsor:

Mayo Clinic

Code:

NCT06377696

Conditions

Malignant Brain Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Best Practice

Medical Device Usage and Evaluation

Metformin

Neurocognitive Assessment

Questionnaire Administration

Study Details

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.

Conditions

Malignant Brain Neoplasm

Study ID

NCT06377696

Start date

May 31, 2024

Status verified date

Jul, 2026

Completion date

May 1, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Group A (metformin)

Patients receive metformin PO BID for 12 months. Treatment repeats every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients also wear a wearable device to monitor health and undergo neurocognitive test throughout the study.

active comparator: Group B (usual care)

Patients receive SOC treatment for 12 months. Patients also wear a wearable device to monitor health and undergo neurocognitive test throughout the study.

Interventions

Best Practice

Receive SOC

Medical Device Usage and Evaluation

Wear wearable device

Metformin

Given PO

Neurocognitive Assessment

Undergo neurocognitive test

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Compliance of patients who complete the testing schedule for the cognitive assessments (Feasibility) [ Time Frame: Baseline, 3 months, and 6 months ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Ugur T. Sener, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-07-16.