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NCT02767388 · ClinicalTrials.gov registry record
Electrophysiological Biomarkers of Chemotherapy-related Cognitive Impairment and Recovery
A clinical trial, sponsored by University of Nebraska.
- Completed
- Registry status
- 45
- Enrollment target
NCT02767388: Completed study, sponsored by University of Nebraska.
NCT02767388 is a clinical trial that has completed, run by University of Nebraska. The registered enrollment target is 45 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02767388 has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- 45 participants
- Enrollment target
Study 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
Primary Outcome
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 i
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2016-09-01 |
| Est. Completion | 2018-03-15 |
What the finished NCT02767388 record still lists
NCT02767388 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 45 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02767388 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02767388 about?
NCT02767388 is a clinical study titled "Electrophysiological Biomarkers of Chemotherapy-related Cognitive Impairment and Recovery". 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 th...
What is the current status of trial NCT02767388?
This trial is currently completed. The enrollment target is 45 participants. The study started on 2016-09-01. Estimated completion is 2018-03-15.
Who is sponsoring clinical trial NCT02767388?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
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