Assessment of Cognitive Function in Breast Cancer and Lymphoma Patients Receiving Chemotherapy - Full Text View

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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Lymphoma Memory

U.S. FDA Resources

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:	1200
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

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

University of Rochester

Investigators

Study Chair:

Michelle C. Janelsins, PhD

University of Rochester

More Information

No publications provided

Responsible Party:	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:	January 31, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Rochester:

cognitive function
memory
attention
breast cancer
lymphoma

Additional relevant MeSH terms:

Breast Neoplasms
Lymphoma
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013

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