Assessment of Cognitive Function in Breast Cancer and Lymphoma Patients Receiving Chemotherapy
Overview
Cognitive impairments in cancer patients represent an important clinical problem. Studies to date estimating prevalence of difficulties in memory, executive function, and attention deficits have been limited by small sample sizes and many have lacked healthy control groups. More information is needed on promising biomarkers and allelic variants that may help to determine the etiology of impairment, identify those most vulnerable to impairment, and develop interventions for these difficulties.
This is a longitudinal observational study of cognitive function in breast cancer and lymphoma patients receiving chemotherapy to better understand the prevalence of cognitive difficulties (i.e., problems with memory, executive function, and attention) in these populations.
Key Inclusion Criteria
For a patient to be eligible for participation in this study, all of the following criteria must apply.
Subjects Receiving Chemotherapy:
- Have a diagnosis of invasive breast cancer (stage I-IIIC) or intermediate or high-grade* lymphoma (*defined by the treating physician)
- Be scheduled to begin a course of chemotherapy
- Oral chemotherapy is acceptable
- Previous or concurrent treatment with hormones or biological response modifiers is acceptable. (Subjects receiving biological response modifiers only are not eligible).
- Be chemotherapy naïve
- Life expectancy greater than 10 months
- Be able to speak and read English
- Give written informed consent
Inclusion Criteria, Controls:
- Must be the same gender as the subject receiving chemotherapy
- Must be within 5 years of the age of the subject receiving chemotherapy
- Life expectancy greater than 10 months
- Be able to speak and read English
- Give written informed consent
- Must be willing to participate in the study for the entire period
Key Exclusion Criteria
A patient will not be eligible for participation in this study if any of the following criteria apply.
Subjects Receiving Chemotherapy:
- Must not be currently hospitalized or have been hospitalized within the last year for a psychiatric illness
- Must not be diagnosed with a neurodegenerative disease
- Must not have primary central nervous system (CNS) disease
- Must not have received chemotherapy in the past
- Must not be scheduled to receive concurrent radiation treatment
- Must not have metastatic disease (subjects with breast cancer)
- Must not be pregnant
- Must not be colorblind
Exclusion Criteria, Controls:
- Must not be currently hospitalized or have been hospitalized within the last year for a psychiatric illness
- Must not be diagnosed with a neurodegenerative disease
- Must not have primary CNS disease
- Must not have been diagnosed with cancer or previously have received chemotherapy
- Must not be pregnant or plan on becoming pregnant during the study period
- Must not be colorblind
Learn More
To learn more, visit ClinicalTrials.Gov
Study Type
Observational
Principal Investigator(s)
James Bearden III, MD
Sponsor(s)
Gary Morrow