Electrophysiological Biomarkers of Chemotherapy-related Cognitive Impairment and Recovery

NCT02767388 | Completed Results

• 1 other identifier: 0137-16-EP
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myelodysplastic Syndrome; Effects of Chemotherapy; Mild Cognitive Impairment; Multiple Myeloma; Non-hodgkin Lymphoma; Chronic Lymphocytic Leukemia; Acute Lymphoid Leukemia; Chronic Myeloid Leukemia; Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (4)

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

  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.

  Collected at Study Induction, 1 month after Study Induction, 3 months after Study Induction

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

  Electrophysiological component that measures allocation of attentional resources

  Collected at Study Induction, 1 month after Study Induction, 3 months after Study Induction

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

  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.

  Collected at Study Induction, 1 month after Study Induction, 3 months after Study Induction

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

  Electrophysiological component that measures online storage load

  Collected at Study Induction, 1 month after Study Induction, 3 months after Study Induction

Study Arms (3)

HM - Chemotherapy

Study patients diagnosed with HM that are scheduled to receive chemotherapy treatment.

HM - No Chemotherapy

Study patients diagnosed with HM that are scheduled to receive non-chemotherapy treatment options.

Healthy Controls

Study participants that are demographically matched to HM study patients and meet all inclusion criteria

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The 2008 World Health Organization (WHO) classification is used to diagnose MDS. Patients diagnosed with MDS are stratified into one of five risk categories, based on a prognostic score calculated according to the revised International Prognostics Scoring System (IPSS-R): very-low risk, low risk, intermediate risk, high risk, and very-high risk. IPSS-R scores are estimated from percent of bone marrow blasts, number and depth of cytopenias, and presence of specific cytogenetic abnormalities, collectively reflecting the total number of risk factors.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68132, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum

MeSH Terms

Conditions

Myelodysplastic Syndromes; Cognitive Dysfunction; Multiple Myeloma; Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphoma; Lymphatic Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Myeloid; Myeloproliferative Disorders

Results Point of Contact

• Title: David Anderson
• Organization: University of Nebraska Medical Center

david.anderson@unmc.edu

402-559-6870

Study Officials

• Vijaya Bhatt, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2016
• First Posted: May 10, 2016
• Study Start: September 1, 2016
• Primary Completion: December 11, 2017
• Study Completion: March 15, 2018
• Last Updated: September 29, 2023
• Results First Posted: September 6, 2019

Record last verified: 2023-09

Locations

US (1)