Breast Cancer Clinical Trial
Assessment of Cognitive Function in Breast Cancer and Lymphoma Patients Receiving Chemotherapy
Summary
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.
Eligibility Criteria
Inclusion Criteria:
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
Inclusion Criteria, Long-Term Followup Study:
Must be a subject who had breast cancer, or control who was paired with that subject with breast cancer, who provided CANTAB data at any time-point during assessments 1 through 3.
Exclusion Criteria:
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
Exclusion Criteria, Long-Term Followup Study:
Must not have dementia or any severe neurodegenerative disease that would prohibit the ability to complete cognitive testing.
Must not be colorblind
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There are 14 Locations for this study
Newark Delaware, 19713, United States
Prairie Village Kansas, 66208, United States
Wichita Kansas, 67214, United States
New Orleans Louisiana, 70112, United States
Grand Rapids Michigan, 49503, United States
Minneapolis Minnesota, 55426, United States
Las Vegas Nevada, 89106, United States
Rochester New York, 14642, United States
Winston-Salem North Carolina, 27104, United States
Columbus Ohio, 43215, United States
Dayton Ohio, 45420, United States
Portland Oregon, 97213, United States
Marshfield Wisconsin, 54449, United States
Milwaukee Wisconsin, 53226, United States
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