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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Rochester
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gary Morrow, University of Rochester
ClinicalTrials.gov Identifier:
NCT01382082
First received: June 23, 2011
Last updated: August 2, 2014
Last verified: August 2014
  Purpose

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
Breast Cancer
Lymphoma

Study Type: Observational
Study Design: 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 and at Six Months Follow Up

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Short-term memory [ Time Frame: Before beginning chemotherapy, at completion of chemotherapy and 6 months later ] [ Designated as safety issue: No ]
    Short-term visual memory will be assessed by the computerized Delayed Matching to Sample (DMS) task.


Secondary Outcome Measures:
  • Verbal recognition memory impairment [ Time Frame: Before beginning chemotherapy, at completion of chemotherapy and 6 months later ] [ Designated as safety issue: No ]
    Memory (verbal) will be assessed by the computerized Verbal Recognition Memory (VRM) Task.

  • Executive function impairment [ Time Frame: Before beginning chemotherapy, at completion of chemotherapy and 6 months later ] [ Designated as safety issue: No ]
    Executive function will be assessed by the computerized One Touch Stockings of Cambridge (OTS) planning task. This secondary outcome measure will be total percent correct on this task. Percent correct based on the number of moves involved will also be assessed.

  • Attention impairment [ Time Frame: Before beginning chemotherapy, at completion of chemotherapy and 6 months later ] [ Designated as safety issue: No ]
    Attention will be assessed by the computerized Rapid Visual Information Processing (RVP) task. The second secondary outcome measure will be total latency (ms).


Other Outcome Measures:
  • Difference between memory, executive function and attention impairments at 6 months between breast cancer, lymphoma patients and healthy controls. [ Time Frame: 6 months after completion of chemotherapy ] [ Designated as safety issue: No ]
  • Difference between memory, executive function and attention impairments by validated standard neuropsychological testing and phone based assessment. [ Time Frame: Before beginning chemotherapy, at completion of chemotherapy and 6 months later ] [ Designated as safety issue: No ]
  • Difference between memory, executive function and attention impairments by single self-report question and validated self-report instruments [ Time Frame: Before beginning chemotherapy, at completion of chemotherapy and 6 months later ] [ Designated as safety issue: No ]
  • Relationship between performance on self-report, phone-based cognitive testing, standard neuropsychological testing and computerized testing between the 3 groups. [ Time Frame: Before beginning chemotherapy, at completion of chemotherapy and 6 months later ] [ Designated as safety issue: No ]
  • Association of inflammatory molecules with cognitive functioning [ Time Frame: Before beginning chemotherapy, at completion of chemotherapy and 6 months later ] [ Designated as safety issue: No ]
  • Associations of genetic materials (SNPs) with cognitive functioning [ Time Frame: Before beginning chemotherapy, at completion of chemotherapy and 6 months later ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood


Estimated Enrollment: 1432
Study Start Date: July 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
subjects with breast cancer
subjects with lymphoma
subjects without cancer

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01382082

Locations
United States, New York
University of Rochester Cancer Center Recruiting
Rochester, New York, United States, 14642
Contact: Libby Nagalski    585-275-1364    elizabeth_nagalski@urmc.rochester.edu   
Principal Investigator: Michelle C. Janelsins, PhD         
Sponsors and Collaborators
Gary Morrow
Investigators
Study Chair: Michelle C. Janelsins, PhD University of Rochester
  More Information

No publications provided

Responsible Party: Gary Morrow, Director, URCC CCOP Research Base, University of Rochester
ClinicalTrials.gov Identifier: NCT01382082     History of Changes
Obsolete Identifiers: NCT01330225
Other Study ID Numbers: URCC 10055
Study First Received: June 23, 2011
Last Updated: August 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
cognitive function
memory
attention
breast cancer
lymphoma

Additional relevant MeSH terms:
Lymphoma
Breast Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014