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

University of Rochester NCORP Research Base

Status: Invitation-only

Conditions: Breast Cancer; Lymphoma

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01382082

UG1CA189961 (U.S. NIH Grant/Contract)

U10CA037420 (U.S. NIH Grant/Contract)

URCC-10055

Details and patient eligibility

About

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.

Enrollment: 1,432 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,432 participants in 3 patient groups

subjects with breast cancer

subjects with lymphoma

subjects without cancer