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

Status:	Active, not recruiting
Conditions:	Breast Cancer, Cancer, Lymphoma
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	21 - Any
Updated:	3/2/2019
Start Date:	May 17, 2011
End Date:	December 27, 2020

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.

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

We found this trial at

sites

Southeast Clinical Oncology Research Program

Winston-Salem, North Carolina 27104

Phone: 336-777-3036

from

Winston-Salem, NC