N/A
N=45
Electrophysiological Biomarkers of Chemotherapy-related Cognitive Impairment and Recovery
Myelodysplastic Syndrome · Effects of Chemotherapy · Mild Cognitive Impairment · Multiple Myeloma · Non-hodgkin Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT02767388 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Change From Baseline Capture Task Performance at 1- and 3- Months — .103; -.039; .066; .067 change in proportional response time
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of Nebraska
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Capture Task Performance at 1- and 3- Months |
.103; -.039; .066; .067; -.002; -.084 | — |
| PRIMARY Change From Baseline N2pc Amplitude at 1- and 3- Months |
.47; -.02; -.34; .41; .36; -.63 | — |
| PRIMARY Change From Baseline Filter Task Performance at 1- and 3- Months |
-.013; .011; -.004; .002; -.006; -.006 | — |
| PRIMARY Change From Baseline CDA Amplitude at 1- and 3- Months |
.30; -.22; -.09; -.34; -.10; -.27 | — |
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.
Eligibility Criteria
Inclusion criteria
- HM diagnosis
- scheduled to receive treatment based on risk classification
- between 19 to 80 years of age-
- normal or corrected-to-normal vision
- matched to HM patient demographics (healthy controls)
Exclusion criteria
- non-HM non-cutaneous cancer diagnosis (patients with localized skin cancer may not be excluded)
- prior radiation or chemotherapy treatment
- HM cancer diagnosis (healthy controls)
Data sourced from ClinicalTrials.gov (NCT02767388). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.