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

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ClinicalTrials.gov Identifier: NCT01382082
Recruitment Status : Enrolling by invitation
First Posted : June 27, 2011
Last Update Posted : July 7, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Michelle Janelsins, PhD, MPH, University of Rochester NCORP Research Base

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.


Condition or disease
Breast Cancer Lymphoma

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Study Type : Observational
Estimated Enrollment : 1432 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Actual Study Start Date : May 17, 2011
Estimated Primary Completion Date : June 14, 2024
Estimated Study Completion Date : June 14, 2024

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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 Outcome Measures :
  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 years post chemotherapy ]
    Delayed match to sample score

  6. attention [ Time Frame: 8 years post chemotherapy ]
    Rapid Visual Processing speed score

  7. Self-report score [ Time Frame: 8 years post-chemotherapy ]
    FACT-Cog


Other Outcome Measures:
  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


Biospecimen Retention:   Samples Without DNA
Blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01382082


Locations
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United States, Delaware
Delaware/Christiana Care NCORP
Newark, Delaware, United States, 19713
United States, Kansas
Kansas City Clinical Oncology Program
Prairie Village, Kansas, United States, 66208
Wichita NCORP
Wichita, Kansas, United States, 67214
United States, Louisiana
Gulf South MU-NCORP
New Orleans, Louisiana, United States, 70112
United States, Michigan
Cancer Research Consortium of West Michigan
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
Metro Minnesota NCORP
Minneapolis, Minnesota, United States, 55426
United States, Nevada
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New York
University of Rochester Cancer Center
Rochester, New York, United States, 14642
United States, North Carolina
Southeast Clinical Oncology Research Program
Winston-Salem, North Carolina, United States, 27104
United States, Ohio
Columbus NCORP
Columbus, Ohio, United States, 43215
Dayton Community Oncology Program
Dayton, Ohio, United States, 45420
United States, Oregon
Pacific Cancer Research Consortium Ncorp
Portland, Oregon, United States, 97213
United States, Wisconsin
Wisconsin NCORP
Marshfield, Wisconsin, United States, 54449
Aurora NCORP
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
University of Rochester NCORP Research Base
National Cancer Institute (NCI)
Investigators
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Study Chair: Michelle C. Janelsins, PhD University of Rochester
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michelle Janelsins, PhD, MPH, Associate Professor of Surgery, Radiation Oncology, and Neuroscience, University of Rochester NCORP Research Base
ClinicalTrials.gov Identifier: NCT01382082    
Obsolete Identifiers: NCT01330225
Other Study ID Numbers: URCC-10055
UG1CA189961 ( U.S. NIH Grant/Contract )
U10CA037420 ( U.S. NIH Grant/Contract )
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: July 7, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michelle Janelsins, PhD, MPH, University of Rochester NCORP Research Base:
cognitive function
memory
attention
breast cancer
lymphoma
Additional relevant MeSH terms:
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Lymphoma
Breast Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Breast Diseases
Skin Diseases