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

Sponsor
University of Rochester NCORP Research Base (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT01382082
Collaborator
National Cancer Institute (NCI) (NIH)
1,432
Enrollment
14
Locations
181.5
Anticipated Duration (Months)
102.3
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated 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
    Anticipated Primary Completion Date :
    Jun 30, 2026
    Anticipated Study Completion Date :
    Jun 30, 2026

    Arms and Interventions

    Arm Intervention/Treatment
    subjects with breast cancer
    subjects with lymphoma
    subjects without cancer

    Outcome Measures

    Primary Outcome Measures

    1. Short-term memory [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 [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 [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 [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 [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 [8 years post chemotherapy]

      Delayed match to sample score

    6. attention [8 years post chemotherapy]

      Rapid Visual Processing speed score

    7. Self-report score [8 years post-chemotherapy]

      FACT-Cog

    Other Outcome Measures

    1. correlation of cognitive function with TNF alpha pathway biomarkers [change from pre to post chemotherapy and six month follow up]

      serum assaying the change in the TNF pathway

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Delaware/Christiana Care NCORP Newark Delaware United States 19713
    2 Kansas City Clinical Oncology Program Prairie Village Kansas United States 66208
    3 Wichita NCORP Wichita Kansas United States 67214
    4 Gulf South MU-NCORP New Orleans Louisiana United States 70112
    5 Cancer Research Consortium of West Michigan Grand Rapids Michigan United States 49503
    6 Metro Minnesota NCORP Minneapolis Minnesota United States 55426
    7 CCOP - Nevada Cancer Research Foundation Las Vegas Nevada United States 89106
    8 University of Rochester Cancer Center Rochester New York United States 14642
    9 Southeast Clinical Oncology Research Program Winston-Salem North Carolina United States 27104
    10 Columbus NCORP Columbus Ohio United States 43215
    11 Dayton Community Oncology Program Dayton Ohio United States 45420
    12 Pacific Cancer Research Consortium Ncorp Portland Oregon United States 97213
    13 Wisconsin NCORP Marshfield Wisconsin United States 54449
    14 Aurora NCORP Milwaukee Wisconsin United States 53226

    Sponsors and Collaborators

    • University of Rochester NCORP Research Base
    • National Cancer Institute (NCI)

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Michelle Janelsins, PhD, MPH, Associate Professor of Surgery, Radiation Oncology, and Neuroscience, University of Rochester NCORP Research Base
    ClinicalTrials.gov Identifier:
    NCT01382082
    Other Study ID Numbers:
    • URCC-10055
    • UG1CA189961
    • U10CA037420
    • NCT01330225
    First Posted:
    Jun 27, 2011
    Last Update Posted:
    May 12, 2022
    Last Verified:
    May 1, 2022
    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, Associate Professor of Surgery, Radiation Oncology, and Neuroscience, University of Rochester NCORP Research Base
    cognitive function
    memory
    attention
    breast cancer
    lymphoma
    Additional relevant MeSH terms:
    Lymphoma
    Breast Neoplasms

    Study Results

    No Results Posted as of May 12, 2022