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临床试验/NCT02767388
NCT02767388已完成不适用

Electrophysiological Biomarkers of Chemotherapy-related Cognitive Impairment and Recovery

University of Nebraska1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2016年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
Change From Baseline Capture Task Performance at 1- and 3- Months

研究概览

简要总结

Broadly speaking, the goal of this study is to better understand the influence of chemotherapy treatment on the cognitive and neural mechanisms underlying human behavior. Extant literature lacks diversity in studied cancer populations and treatment protocols, and provides limited understanding of the cognitive abilities that are impaired by chemotherapy. To overcome these limitations, this study will employ a sophisticated battery of tests on an understudied cancer population. Eligible participants will either be patients diagnosed with hematological malignancy (HM) or demographically matched healthy control patients.

After HM diagnosis and treatment protocols have been established, patients will be inducted into the longitudinal study comprised of three visits: 1) after diagnosis but prior to chemotherapy treatment (baseline), 2) after one treatment cycle (one month post-baseline), and 3) after three treatment cycles (three months post-baseline). Patients will undergo a test battery designed to measure specific behavioral and neural mechanisms of attention; tests will either be computer-based cognitive tasks or simulated driving tests that immerse patients into virtual driving scenarios. During each test, EEG will be concurrently measured through non-invasive scalp electrophysiology recordings; EEG recordings will reveal underlying neural mechanisms affected by chemotherapy. Additionally, neuropsychological tests of vision, attention, and memory will be administered, as well as questionnaires to evaluate health, mobility, and life space. Finally, blood samples will be collected to examine levels of circulating inflammation-specific proteins typically present in cancer patients. This study will allow us to better understand the mechanisms through which chemotherapy influences cognitive performance. Results from this study will influence the administration of chemotherapy treatments so that patients can continue to receive the highest medical care while maintaining optimal cognitive abilities and quality of life.

详细描述

The broad goal of this research project is to develop a core set of biomarkers for chemotherapy-related cognitive impairment (or chemobrain). Clinical studies have documented mild cognitive impairment in chemotherapy patients most frequently within the domains of attention and memory, though impairments have been observed across a broad range of cognitive abilities. In addition, neuroimaging studies have demonstrated chemotherapy-related structural and functional changes in distributed cortical areas, including regions of the fronto-parietal attention network. While these studies suggest chemotherapy treatment negatively impacts patient health and cognitive function, it remains unclear how chemotherapy affects neural mechanisms of cognitive abilities. Current literature is limited in four major ways: (1) most research has focused on breast cancer populations, providing little insight into impact of tumor type, (2) few studies have examined the parametric effects of chemotherapy toxicity, (3) neuropsychological exams provide weak resolution of specific cognitive functions, and (4) neural factors associated with cognitive impairment are difficult to dissociate from non-neural (e.g. psychosocial) factors. To overcome these central limitations, the investigators propose a one-year longitudinal study that aims to systematically examine the influence of cancer stage and treatment toxicity on mild cognitive impairment observed in hematological malignancy (HM) patients by implementing a core battery of behavioral and neural measures of attention.

Our specific aims (SA) are to:

SA1: Quantify chemotherapy-related impairments of attention-specific processes in HM patients.

H1a: No difference in behavioral measures of attention will be observed across HM groups prior to treatment, and HM groups will perform worse than healthy controls.

H1b: Exposure to chemotherapy will predict behavioral impairments of attention, and the magnitude of impairment will be linked with treatment toxicity.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
19 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change From Baseline Capture Task Performance at 1- and 3- Months

时间窗: Collected at Study Induction, 1 month after Study Induction, 3 months after Study Induction

Response time - measured as the time required to respond to a target hidden among distractor items - is the primary outcome measure of the capture task. Proportional response time was calculated by subtracting mean response time in the neutral condition from response time in the capture condition, and dividing that number by the standard deviation of response time across conditions. Changes in proportional response time across study visits is reported. Positive values correspond to an increase in response time and negative values correspond to a decrease in response time.

Change From Baseline CDA Amplitude at 1- and 3- Months

时间窗: Collected at Study Induction, 1 month after Study Induction, 3 months after Study Induction

Electrophysiological component that measures online storage load

Change From Baseline N2pc Amplitude at 1- and 3- Months

时间窗: Collected at Study Induction, 1 month after Study Induction, 3 months after Study Induction

Electrophysiological component that measures allocation of attentional resources

Change From Baseline Filter Task Performance at 1- and 3- Months

时间窗: Collected at Study Induction, 1 month after Study Induction, 3 months after Study Induction

Response accuracy - measured as the proportion of correct trials - is the primary outcome measure of the filter task. Changes in response accuracy were calculated by subtracting response accuracy at 1-month and 3-months from baseline response accuracy. Positive values correspond to an increase in accuracy and negative values correspond to a decline in accuracy.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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