Malignant Brain NeoplasmPhase 2NCT06377696
Remote Cognitive Assessment and Wearable Device While Assessing the Impact of Metformin in Patients With History of Cranial Radiation Therapy
A Phase 2 study testing Best Practice, Medical Device Usage and Evaluation and Metformin in people with Malignant Brain Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Brain Neoplasm
- What is being tested?
- Best Practice, Medical Device Usage and Evaluation and Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2024to 1 Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Neuro-Oncology Anywhere: Deploying Mayo Clinic's Remote Cognitive Assessment Battery and Wearable Device Monitoring Platform While Assessing the Impact of Metformin on Cognition and Quality of Life in Patients With History of Cranial Radiation
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.) 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. wearable device only.
IV. Assess the safety and tolerability of metformin in patients who have previously received cranial radiation.
EXPLORATORY OBJECTIVES:
- 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.
- Conditions
- Malignant Brain Neoplasm
- Being tested
- Best Practice, Medical Device Usage and Evaluation, Metformin, Neurocognitive Assessment, Questionnaire Administration
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive SOC
Medical Device Usage and EvaluationOther
Wear wearable device
MetforminDrug
Also called N,N-dimethylbiguanide
Given PO
Neurocognitive AssessmentOther
Undergo neurocognitive test
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Best Practice; Other: Medical Device Usage and Evaluation; Other: Neurocognitive Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, and 6 months
Secondary outcomes (5)
Overall completion rates and compliance (Feasibility)
Will evaluate compliance of completing the patient-reported symptom assessments and the activity and sleep assessments and will assess for any patterns within and between the treatment arms.
Measured: Up to 12 months
Overall satisfaction
Satisfaction/acceptance rates will be evaluated using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C-30, which consists of 30 questions, each answered on a 4-point (e.g., not at all, a little, quite a bit, very much) or a scale of 1-7 where 1=very poor and 7=excellent.
Measured: Up to 12 months
Adherence (Feasibility)
Adherence to study drug will be evaluated in those randomized to the metformin treatment group. Will consider sufficient adherence to be defined as taking at least 80% of the prescribed doses.
Measured: Up to 12 months
Neurocognitive scores
Neurocognitive scores will be assessed using the Mayo Test Drive, a web-based platform for remote self-administered cognitive assessment that uses the Stricker Learning Span (SLS), which is a computer adaptive word-list memory test that matches test difficulty to user performance, and the Symbols test, which is a measure of processing speed and executive functioning that requires timed visual matching. The primary outcome measure will be the Mayo Test Drive raw composite (range 0 - 158). Higher scores indicate better cognitive test performance. Several secondary outcome measures will also be analyzed including but not limited to SLS sum of trials (0-108), an accuracy-weighted Symbols score (0-50), and Symbols average response time for correct items (0+). Participants will have opportunity to provide comments about the testing experience.
Measured: Up to 12 months
Incidence of adverse events (AEs)
Safety and tolerability will be assessed on those randomized to receive metformin, as defined using the Common Terminology Criteria for Adverse Events version 5. Any AEs will be summarized with the maximum grade of each AE reported for each patient.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start31 May 2024
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Brain NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ugur T. Sener, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377696
- Sponsor's protocol ID
- MC230713
- Other IDs
- 23-005512
- Status last verified
- Sep 2026
- First submitted
- 16 Apr 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Sener U, Neth B, Galloway T, Hughes H, Caron S, Batty NR, Alden EC, Stricker NH, Stricker JL, Kizilbash SH, Breen WG, Lehrer E, Campian J, Uhm J, Ruff MW, D'Andre SD, Burns TC, Haddad TC, Flickinger LM, Chan K, Mead-Harvey C, Geyer SM. Protocol for Neuro-Oncology Anywhere: Deploying Mayo Clinic's remote cognitive assessment battery and wearable device monitoring platform while assessing the impact of metformin on cognition and quality of life in patients with history of cranial radiation. Contemp Clin Trials Commun. 2026 May 18;51:101648. doi: 10.1016/j.conctc.2026.101648. eCollection 2026 Jun.
PubMed 42211793
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuro-Oncology Anywhere: Deploying Mayo Clinic's Remote Cognitive Assessment Battery and Wearable Device Monitoring Platform While Assessing the Impact of Metformin on Cognition and Quality of Life in Patients With History of Cranial Radiation
- ClinicalTrials.gov ID
- NCT06377696
- Acronym / sponsor ID
- MC230713
- Conditions
- Malignant Brain Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 31 May 2024 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.) 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. wearable device only.
IV. Assess the safety and tolerability of metformin in patients who have previously received cranial radiation.
EXPLORATORY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (metformin) | Experimental | Other: Medical Device Usage and Evaluation, Drug: Metformin, Other: Neurocognitive Assessment, Other: Questionnaire AdministrationPatients 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 B (usual care) | Active comparator | Other: Best Practice, Other: Medical Device Usage and Evaluation, Other: Neurocognitive Assessment, Other: Questionnaire AdministrationPatients receive SOC treatment for 12 months. Patients also wear a wearable device to monitor health and undergo neurocognitive test throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive SOC | Other | Group B (usual care) |
| Medical Device Usage and EvaluationWear wearable device | Other | Group A (metformin), Group B (usual care) |
| MetforminAlso: N,N-dimethylbiguanideGiven PO | Drug | Group A (metformin) |
| Neurocognitive AssessmentUndergo neurocognitive test | Other | Group A (metformin), Group B (usual care) |
| Questionnaire AdministrationAncillary studies | Other | Group A (metformin), Group B (usual care) |
Primary outcome
Compliance of patients who complete the testing schedule for the cognitive assessments (Feasibility)
Time frame: Baseline, 3 months, and 6 months
Feasibility will be assessed based on compliance of patients to the testing schedule for the cognitive assessments using the Mayo Test Drive tool.
5 secondary outcomes
Overall completion rates and compliance (Feasibility)
Time frame: Up to 12 months
Overall satisfaction
Time frame: Up to 12 months
Adherence (Feasibility)
Time frame: Up to 12 months
Neurocognitive scores
Time frame: Up to 12 months
Incidence of adverse events (AEs)
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Derived from this study: PubMed 42211793Sener U, Neth B, Galloway T, Hughes H, Caron S, Batty NR, Alden EC, Stricker NH, Stricker JL, Kizilbash SH, Breen WG, Lehrer E, Campian J, Uhm J, Ruff MW, D'Andre SD, Burns TC, Haddad TC, Flickinger LM, Chan K, Mead-Harvey C, Geyer SM. Protocol for Neuro-Oncology Anywhere: Deploying Mayo Clinic's remote cognitive assessment battery and wearable device monitoring platform while assessing the impact of metformin on cognition and quality of life in patients with history of cranial radiation. Contemp Clin Trials Commun. 2026 May 18;51:101648. doi: 10.1016/j.conctc.2026.101648. eCollection 2026 Jun.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ugur T. Sener, MD principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Best Practice, Medical Device Usage and Evaluation and Metformin in people with Malignant Brain Neoplasm, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance of patients who complete the testing schedule for the cognitive assessments (Feasibility) (time frame: Baseline, 3 months, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06377696, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.