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Breast CancerCANTABNCT01382082

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

An observational study of Breast Cancer and Lymphoma, run by University of Rochester NCORP Research Base at 29 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for
Breast Cancer, Lymphoma
How many people
1,432 participants
Where
29 sitesUnited States
Study dates
14 Jul 2011to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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
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  • Life expectancy greater than 10 months
  • Be able to speak and read English
  • Give written informed consent
  • 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
  • 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.

Who cannot join

  • 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
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  • Must not have metastatic disease (subjects with breast cancer)
  • Must not be pregnant
  • Must not be colorblind
  • 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
  • Must not have dementia or any severe neurodegenerative disease that would prohibit the ability to complete cognitive testing.
  • Must not be colorblind

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

United States29 sites

  • Columbus NCORP

    Columbus, Ohio, 43215

  • Columbus

    Columbus, Ohio, 43215

  • Dayton Community Oncology Program

    Dayton, Ohio, 45420

  • Dayton

    Dayton, Ohio, 45459

  • Heartland

    Decatur, Illinois, 62526

  • Hem Onc CNY

    East Syracuse, New York, 13057

  • Cancer Research Consortium of West Michigan

    Grand Rapids, Michigan, 49503

  • CRCWM

    Grand Rapids, Michigan, 49503

  • NCORP of the Carolinas

    Greenville, South Carolina, 29605

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Nevada

    Las Vegas, Nevada, 89106

  • Wisconsin NCORP

    Marshfield, Wisconsin, 54449

  • Aurora NCORP

    Milwaukee, Wisconsin, 53226

  • Metro Minnesota NCORP

    Minneapolis, Minnesota, 55426

  • Gulf South MU-NCORP

    New Orleans, Louisiana, 70112

  • Delaware/Christiana Care NCORP

    Newark, Delaware, 19713

  • Delaware/Christiana Care NCORP (CHRISTIANA)

    Newark, Delaware, 19718

  • Pacific Cancer Research Consortium Ncorp

    Portland, Oregon, 97213

  • PCRC

    Portland, Oregon, 97213

  • Kansas City Clinical Oncology Program

    Prairie Village, Kansas, 66208

  • Kansas City

    Rochester, New York, 14642

  • University of Rochester Cancer Center

    Rochester, New York, 14642

  • Metro Minnesota Community Oncology Research Consortium

    Saint Louis Park, Minnesota, 55416

  • Northwest (Virginia Mason)

    Seattle, Washington, 98101

  • Upstate Carolina

    Spartanburg, South Carolina, 29303

  • Wichita NCORP

    Wichita, Kansas, 67214

  • Wichita

    Wichita, Kansas, 67214

  • Novant Health Cancer Institute - Kernersville

    Winston-Salem, North Carolina, 27103

  • Southeast Clinical Oncology Research Program

    Winston-Salem, North Carolina, 27104

Other trials in United States

About this study

Official 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

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.

Keywords
cognitive function, memory, attention, breast cancer, lymphoma
Medical subject headings
Breast Neoplasms, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01382082
Study groupRoleWhat they receive
subjects with breast cancerNot described
subjects with lymphomaNot described
subjects without cancerNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Short-term memory

    Change in Short-term visual memory will be assessed by the computerized Delayed Matching to Sample (DMS) task.

    Measured: 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 outcomes (7)

  1. Attention impairment

    Change in attention will be assessed by the computerized Rapid Visual Information Processing (RVP) task.

    Measured: 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

  2. Verbal recognition memory impairment

    Change in Memory (verbal) will be assessed by the computerized Verbal Recognition Memory (VRM) Task.

    Measured: 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

  3. Executive function impairment

    Change in Executive function will be assessed by the computerized One Touch Stockings of Cambridge (OTS) planning task.

    Measured: 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

  4. Self-report score

    FACT-Cog change score

    Measured: 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

  5. short term memory

    Delayed match to sample score

    Measured: 8 and/or 10 years post-chemotherapy

  6. attention

    Rapid Visual Processing speed score

    Measured: 8 and/or 10 years post-chemotherapy

  7. Self-report score

    FACT-Cog

    Measured: 8 and/or 10 years post-chemotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2011 (estimated)
  2. Study start14 Jul 2011
  3. Primary completion31 Jul 2026
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
1,432 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01382082
Sponsor's protocol ID
URCC-10055
Other IDs
UG1CA189961, U10CA037420
Acronym
CANTAB
Status last verified
Oct 2026
First submitted
23 Jun 2011
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kleckner AS, Kleckner IR, Culakova E, Shayne M, Belcher EK, Gudina AT, Williams AM, Onitilo AA, Hopkins JO, Gross H, Mustian KM, Peppone LJ, Janelsins MC. The association between cancer-related fatigue and diabetes from pre-chemotherapy to 6 months post-chemotherapy. Support Care Cancer. 2022 Sep;30(9):7655-7663. doi: 10.1007/s00520-022-07189-x. Epub 2022 Jun 9.

    PubMed 35678881

  • Gilmore N, Mohile S, Lei L, Culakova E, Mohamed M, Magnuson A, Loh KP, Maggiore R, Belcher E, Conlin A, Weiselberg L, Ontko M, Janelsins M. The longitudinal relationship between immune cell profiles and frailty in patients with breast cancer receiving chemotherapy. Breast Cancer Res. 2021 Feb 5;23(1):19. doi: 10.1186/s13058-021-01388-w.

    PubMed 33546731

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer and Lymphoma, run by University of Rochester NCORP Research Base at 29 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01382082, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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