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NCT Number: NCT01382082

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Delaware/Christiana Care NCORP, Newark, Delaware, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. short term memory

    Time frame: 8 and/or 10 years post-chemotherapy

    Delayed match to sample score

  6. attention

    Time frame: 8 and/or 10 years post-chemotherapy

    Rapid Visual Processing speed score

  7. Self-report score

    Time frame: 8 and/or 10 years post-chemotherapy

    FACT-Cog

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Rochester NCORP Research Base

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: CANTAB

Important dates

Study start
2011
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2011
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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