CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 45 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT02767388
NCT02767388N/ACompleted

Electrophysiological Biomarkers of Chemotherapy-related Cognitive Impairment and Recovery

University of Nebraska·observational·Posted May 10, 2016·Updated Sep 29, 2023

In Brief

An observational study for Myelodysplastic Syndrome and 8 related conditions. Completed, enrolled 45 participants across 1 site.

Detailed Summary

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.

Study Details

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMay 10, 2016
Enrollment StartSep 1, 2016
Primary CompletionDec 11, 2017
Study CompletionMar 15, 2018
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.1 years ago