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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Compliance of patients who complete the testing schedule for the cognitive assessments (Feasibility)
研究概览
简要总结
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.
详细描述
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.) not.
II. Evaluate compliance and feasibility in terms of the adherence to study drug in those randomized to receive metformin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Metformin (Drug)
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Neurocognitive Assessment (Other)
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Medical Device Usage and Evaluation (Other)
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.
干预措施: Neurocognitive Assessment (Other)
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.
干预措施: Best Practice (Other)
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.
干预措施: Medical Device Usage and Evaluation (Other)
结局指标
主要结局
Compliance of patients who complete the testing schedule for the cognitive assessments (Feasibility)
时间窗: 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.
次要结局
- Adherence (Feasibility)(Up to 12 months)
- Overall completion rates and compliance (Feasibility)(Up to 12 months)
- Overall satisfaction(Up to 12 months)
- Neurocognitive scores(Up to 12 months)
- Incidence of adverse events (AEs)(Up to 2 years)