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

June 23, 2011
August 2, 2014
July 2011
April 2015   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT01382082 on ClinicalTrials.gov Archive Site
  • 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).
Not Provided
  • 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 ]
Not Provided
 
Assessment of Cognitive Function in Breast Cancer and Lymphoma Patients Receiving Chemotherapy
Assessment of Cognitive Function in Breast Cancer and Lymphoma Patients Receiving Chemotherapy at Pre-Treatment,Post-Treatment and at Six Months Follow Up

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Blood

Non-Probability Sample

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.

  • Breast Cancer
  • Lymphoma
Not Provided
  • subjects with breast cancer
  • subjects with lymphoma
  • subjects without cancer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1432
April 2015
April 2015   (final data collection date for primary outcome measure)

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
Both
21 Years and older
Yes
United States
 
NCT01382082
URCC 10055
Yes
Gary Morrow, University of Rochester
Gary Morrow
National Cancer Institute (NCI)
Study Chair: Michelle C. Janelsins, PhD University of Rochester
University of Rochester
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP