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

Assessment of Cognitive Function in Breast Cancer and Lymphoma Patients Receiving Chemotherapy at Pre-Treatment, Post-Treatment, at Six Month Follow-Up, and Long-Term Follow-Ups

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01382082
Acronym
CANTAB
Enrollment
1432
Registered
2011-06-27
Start date
2011-07-14
Completion date
2026-12-31
Last updated
2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Lymphoma

Keywords

cognitive function, memory, attention, breast cancer, lymphoma

Brief 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.

Interventions

None listed

Sponsors

University of Rochester NCORP Research Base
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Short-term memoryLongitudinal Mixed Model assessing change over time from pre to post chemotherapy and at 6 month follow-up assessing change from pre to post chemotherapy and pre to 6 months post-chemotherapy in patients compared to controlsChange in Short-term visual memory will be assessed by the computerized Delayed Matching to Sample (DMS) task.

Secondary

MeasureTime frameDescription
Attention impairmentLongitudinal Mixed Model assessing change over time from pre to post chemotherapy and at 6 month follow-up assessing change from pre to post chemotherapy and pre to 6 months post-chemotherapy in patients compared to controlsChange in attention will be assessed by the computerized Rapid Visual Information Processing (RVP) task.
Verbal recognition memory impairmentLongitudinal Mixed Model assessing change over time from pre to post chemotherapy and at 6 month follow-up assessing change from pre to post chemotherapy and pre to 6 months post-chemotherapy in patients compared to controlsChange in Memory (verbal) will be assessed by the computerized Verbal Recognition Memory (VRM) Task.
Executive function impairmentLongitudinal Mixed Model assessing change over time from pre to post chemotherapy and at 6 month follow-up assessing change from pre to post chemotherapy and pre to 6 months post-chemotherapy in patients compared to controlsChange in Executive function will be assessed by the computerized One Touch Stockings of Cambridge (OTS) planning task.
Self-report scoreLongitudinal Mixed Model assessing change over time from pre to post chemotherapy and at 6 month follow-up assessing change from pre to post chemotherapy and pre to 6 months post-chemotherapy in patients compared to controlsFACT-Cog change score
short term memory8 and/or 10 years post-chemotherapyDelayed match to sample score
attention8 and/or 10 years post-chemotherapyRapid Visual Processing speed score

Countries

United States

Contacts

STUDY_CHAIRMichelle C. Janelsins, PhD

University of Rochester

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026