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Anti-diabetic agent

Metformin and Remote Monitoring for Brain Cancer

Phase 2
Recruiting
Led By Ugur T. Sener, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, AND Karnofsky performance status (KPS) of ≥ 70
Must not have
Pregnant or nursing, imprisoned, or lacking capacity for understanding
Currently taking the study agent (i.e., metformin), and cannot safely discontinue if randomized to the control group (Group B)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Summary

This trial aims to see if patients who have had cranial radiation can receive care remotely. They will be given metformin, a drug used to treat diabetes, to see if it helps with cognitive

Who is the study for?
This trial is for patients who have had cranial radiation therapy due to brain cancer or tumors. It's designed to see if care can be managed remotely using a web platform and wearable devices, and whether metformin helps prevent cognitive decline post-radiation.
What is being tested?
The study tests remote patient care via the Mayo Test Drive platform and monitors physical activity with wearable devices. It also examines if metformin reduces cognitive issues after skull radiation compared to those not taking it.
What are the potential side effects?
Potential side effects are not detailed in the provided information but may include typical reactions to metformin such as digestive upset, headaches, and possible skin reactions from wearing devices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am mostly active and can care for myself, with a KPS score of 70 or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant, nursing, imprisoned, or unable to understand my condition.
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I am currently on metformin and cannot safely stop if needed.
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I am not taking supplements like resveratrol, CoQ10, coconut oil, or curcumin, or I am willing to stop taking them for the study.
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I cannot swallow pills or my body might not absorb them well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Compliance of patients who complete the testing schedule for the cognitive assessments (Feasibility)
Secondary outcome measures
Adherence (Feasibility)
Incidence of adverse events (AEs)
Neurocognitive scores
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group A (metformin)Experimental Treatment4 Interventions
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.
Group II: Group B (usual care)Active Control4 Interventions
Patients receive SOC treatment for 12 months. Patients also wear a wearable device to monitor health and undergo neurocognitive test throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,298 Previous Clinical Trials
3,958,345 Total Patients Enrolled
Ugur T. Sener, M.D.Principal InvestigatorMayo Clinic in Rochester
~67 spots leftby May 2027
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