Assessment of Cognitive Function in Breast Cancer and Lymphoma Patients Receiving Chemotherapy

Running, not enrolling

Conditions studied: Breast Cancer, Lymphoma

In brief

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 facts

Study ID

NCT01382082

Run by

University of Rochester NCORP Research Base

People needed

1432

Starts

2011-07-14

Expected to finish

2026-12-31

Last updated by the study team

2026-04-24

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Delaware/Christiana Care NCORP — Newark, Delaware, United States
• Delaware/Christiana Care NCORP (CHRISTIANA) — Newark, Delaware, United States
• Heartland — Decatur, Illinois, United States
• Kansas City Clinical Oncology Program — Prairie Village, Kansas, United States
• Wichita NCORP — Wichita, Kansas, United States
• Wichita — Wichita, Kansas, United States
• Gulf South MU-NCORP — New Orleans, Louisiana, United States
• Cancer Research Consortium of West Michigan — Grand Rapids, Michigan, United States
• CRCWM — Grand Rapids, Michigan, United States
• Metro Minnesota NCORP — Minneapolis, Minnesota, United States
• Metro Minnesota Community Oncology Research Consortium — Saint Louis Park, Minnesota, United States
• CCOP - Nevada Cancer Research Foundation — Las Vegas, Nevada, United States
• Nevada — Las Vegas, Nevada, United States
• Hem Onc CNY — East Syracuse, New York, United States
• Kansas City — Rochester, New York, United States
• University of Rochester Cancer Center — Rochester, New York, United States
• Novant Health Cancer Institute - Kernersville — Winston-Salem, North Carolina, United States
• Southeast Clinical Oncology Research Program — Winston-Salem, North Carolina, United States
• Columbus NCORP — Columbus, Ohio, United States
• Columbus — Columbus, Ohio, United States
• Dayton Community Oncology Program — Dayton, Ohio, United States
• Dayton — Dayton, Ohio, United States
• Pacific Cancer Research Consortium Ncorp — Portland, Oregon, United States
• PCRC — Portland, Oregon, United States
• NCORP of the Carolinas — Greenville, South Carolina, United States

Full record on ClinicalTrials.gov

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