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

NCT06377696 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: MC230713NCI-2024-0298023-005512
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Compliance of patients who complete the testing schedule for the cognitive assessments (Feasibility)

  Feasibility will be assessed based on compliance of patients to the testing schedule for the cognitive assessments using the Mayo Test Drive tool.

  Baseline, 3 months, and 6 months

Secondary Outcomes (5)

• Overall completion rates and compliance (Feasibility)

  Up to 12 months

• Overall satisfaction

  Up to 12 months

• Adherence (Feasibility)

  Up to 12 months

• Neurocognitive scores

  Up to 12 months

• Incidence of adverse events (AEs)

  Up to 2 years

Study Arms (2)

Group A (metformin)

EXPERIMENTAL

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.

Other: Medical Device Usage and Evaluation; Drug: Metformin; Other: Neurocognitive Assessment; Other: Questionnaire Administration

Group B (usual care)

ACTIVE COMPARATOR

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

Other: Best Practice; Other: Medical Device Usage and Evaluation; Other: Neurocognitive Assessment; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Receive SOC

Also known as: standard of care, standard therapy

Group B (usual care)

Medical Device Usage and Evaluation OTHER

Wear wearable device

Group A (metformin); Group B (usual care)

Metformin DRUG

Given PO

Also known as: N,N-dimethylbiguanide

Group A (metformin)

Neurocognitive Assessment OTHER

Undergo neurocognitive test

Group A (metformin); Group B (usual care)

Questionnaire Administration OTHER

Ancillary studies

Group A (metformin); Group B (usual care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care; Metformin; Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Biguanides; Guanidines; Amidines; Organic Chemicals; Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Ugur T. Sener, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 22, 2024
• Study Start: May 31, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

US (1)