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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More 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 3 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06377696
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Mayo Clinic
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Ugur T. Sener, M.D.
Principal Investigator Affiliation	Mayo Clinic in Rochester
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Malignant Brain Neoplasm

Additional Details

PRIMARY OBJECTIVE:

I. Determine the feasibility of completing serial remote cognitive, activity/sleep, and self-report assessments in clinical trial participants who have previously received cranial radiation.

SECONDARY OBJECTIVES:

I. Assess the acceptance or satisfaction of patients with the remote monitoring in this trial and how these may differ between those who receive metformin versus (vs.#46;) not.

II. Evaluate compliance and feasibility in terms of the adherence to study drug in those randomized to receive metformin.

III. Assess and compare neurocognitive function scores and the impact of receiving metformin + health promotion with wearable device vs.#46; wearable device only.

IV. Assess the safety and tolerability of metformin in patients who have previously received cranial radiation.

EXPLORATORY OBJECTIVES:

I. Investigate the relationship of metformin and other health outcomes such as activity and sleep data and how these compare to the results for patients who are randomized to the control group, who do not receive metformin.

II. Explore potential differences in these compliance and satisfaction measures and how they may correspond to health disparities and social determinants of health.

OUTLINE: Patients are randomized to 1 of 2 groups. GROUP A: Patients receive metformin orally (PO) twice day (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. GROUP B: Patients receive standard of care (SOC) treatment for 12 months. Patients also wear a wearable device to monitor health and undergo neurocognitive test throughout the study. Upon completion of study treatment, patients are followed up at 30 days then every 3 months for up to 2 years.

Arms & Interventions

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

Other: - Best Practice

Receive SOC

Other: - Medical Device Usage and Evaluation

Wear wearable device

Drug: - Metformin

Given PO

Other: - Neurocognitive Assessment

Undergo neurocognitive test

Other: - Questionnaire Administration

Ancillary studies

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic in Rochester, Rochester, Minnesota

Status

Address

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

Site Contact

Clinical Trials Referral Office

[email protected]

855-776-0015