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

April 22, 2026 updated by: Michelle Janelsins, PhD, MPH, University of Rochester NCORP Research Base

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1432

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Newark, Delaware, United States, 19713
        • Delaware/Christiana Care NCORP
      • Newark, Delaware, United States, 19718
        • Delaware/Christiana Care NCORP (CHRISTIANA)
    • Illinois
      • Decatur, Illinois, United States, 62526
        • Heartland
    • Kansas
      • Prairie Village, Kansas, United States, 66208
        • Kansas City Clinical Oncology Program
      • Wichita, Kansas, United States, 67214
        • Wichita NCORP
      • Wichita, Kansas, United States, 67214
        • Wichita
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Gulf South MU-NCORP
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Cancer Research Consortium of West Michigan
      • Grand Rapids, Michigan, United States, 49503
        • CRCWM
    • Minnesota
      • Minneapolis, Minnesota, United States, 55426
        • Metro Minnesota NCORP
      • Saint Louis Park, Minnesota, United States, 55416
        • Metro Minnesota Community Oncology Research Consortium
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • CCOP - Nevada Cancer Research Foundation
      • Las Vegas, Nevada, United States, 89106
        • Nevada
    • New York
      • East Syracuse, New York, United States, 13057
        • Hem Onc CNY
      • Rochester, New York, United States, 14642
        • University of Rochester Cancer Center
      • Rochester, New York, United States, 14642
        • Kansas City
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27104
        • Southeast Clinical Oncology Research Program
      • Winston-Salem, North Carolina, United States, 27103
        • Novant Health Cancer Institute - Kernersville
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Columbus NCORP
      • Columbus, Ohio, United States, 43215
        • Columbus
      • Dayton, Ohio, United States, 45420
        • Dayton Community Oncology Program
      • Dayton, Ohio, United States, 45459
        • Dayton
    • Oregon
      • Portland, Oregon, United States, 97213
        • Pacific Cancer Research Consortium Ncorp
      • Portland, Oregon, United States, 97213
        • PCRC
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • NCORP of the Carolinas
      • Spartanburg, South Carolina, United States, 29303
        • Upstate Carolina
    • Washington
      • Seattle, Washington, United States, 98101
        • Northwest (Virginia Mason)
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Wisconsin NCORP
      • Milwaukee, Wisconsin, United States, 53226
        • Aurora NCORP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

During enrollment, the groups will be balanced on age and gender. Controls of the same age and gender as the subject receiving chemotherapy will be enrolled at the same time.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
subjects with breast cancer
subjects with lymphoma
subjects without cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short-term memory
Time Frame: Longitudinal 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 controls
Change in Short-term visual memory will be assessed by the computerized Delayed Matching to Sample (DMS) task.
Longitudinal 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 controls

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attention impairment
Time Frame: Longitudinal 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 controls
Change in attention will be assessed by the computerized Rapid Visual Information Processing (RVP) task.
Longitudinal 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 controls
Verbal recognition memory impairment
Time Frame: Longitudinal 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 controls
Change in Memory (verbal) will be assessed by the computerized Verbal Recognition Memory (VRM) Task.
Longitudinal 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 controls
Executive function impairment
Time Frame: Longitudinal 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 controls
Change in Executive function will be assessed by the computerized One Touch Stockings of Cambridge (OTS) planning task.
Longitudinal 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 controls
Self-report score
Time Frame: Longitudinal 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 controls
FACT-Cog change score
Longitudinal 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 controls
short term memory
Time Frame: 8 and/or 10 years post-chemotherapy
Delayed match to sample score
8 and/or 10 years post-chemotherapy
attention
Time Frame: 8 and/or 10 years post-chemotherapy
Rapid Visual Processing speed score
8 and/or 10 years post-chemotherapy
Self-report score
Time Frame: 8 and/or 10 years post-chemotherapy
FACT-Cog
8 and/or 10 years post-chemotherapy

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation of cognitive function with TNF alpha pathway biomarkers
Time Frame: change from pre to post chemotherapy and six month follow up
serum assaying the change in the TNF pathway
change from pre to post chemotherapy and six month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester NCORP Research Base

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Michelle C. Janelsins, PhD, University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2011

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 23, 2011

First Submitted That Met QC Criteria

June 24, 2011

First Posted (Estimated)

June 27, 2011

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URCC-10055
  • UG1CA189961 (U.S. NIH Grant/Contract)
  • U10CA037420 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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