Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06377696
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-04-16
Brief Title:
Remote Cognitive Assessment and Wearable Device While Assessing the Impact of Metformin in Patients with History of Cranial Radiation Therapy
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Neuro-Oncology Anywhere Deploying Mayo Clinics 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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
PRIMARY OBJECTIVE
I Determine the feasibility of completing serial remote cognitive activitysleep 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 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
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
I Determine the feasibility of completing serial remote cognitive activitysleep 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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 23-005512 | OTHER | Mayo Clinic Institutional Review Board | None |
| NCI-2024-02980 | REGISTRY | None | None |