Pilot Study of Neuropsychologic and Electrophysiological Features of Cancer-Related Cognitive Side Effects in Racial and Ethnic Minority Breast Cancer Patients

Memorial Sloan Kettering Cancer Center4 sites in 1 country2 target enrollmentNovember 2011

ConditionsBreast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 2
Locations: 4
Primary Endpoint: neuropsychologic (NP) features
Status: Terminated
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is being done to find out if it is possible to enroll minority women with breast cancer in a study of how chemotherapy may affect their ability to answer certain questions and perform certain tasks that measure brain activity. The investigators want to look at thinking and brain activity in patients to see if cancer treatments can cause any brain changes. For this study, women without cancer, are being asked to participate in order to compare the answers to the questions and the brain wave activity measured in the women with cancer to women who don't have cancer.

Registry

clinicaltrials.gov

Start Date

November 2011

End Date

September 2012

Last Updated

13 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Is at least 18 years old, but not older than 61 years old;
•Is female;
•Is Hispanic of any race or Black/African American
•Is fluent in English (see explanation in Section 7.0 Assessment / Evaluation Plan - Language Determination);
•Has a diagnosis of breast cancer (Stage I-III);
•Is treatment naïve and scheduled to receive chemotherapy, radiation, or endocrine therapy.
•Healthy Control Subject Inclusion Criteria
•Is at least 18 years old, but not older than 61 years old;
•Is female;
•Is Hispanic or Black Non-Hispanic;

Exclusion Criteria

•Participants with neurologic illnesses affecting cognition, (i.e., Traumatic Brain Injury with a loss of consciousness \>30 min., etc.) or severe psychiatric illness (i.e., schizophrenia, bipolar disorder, etc.);
•A hearing or visual deficit that impairs the ability to participate in the EEG tasks.
•Any condition which prevents application of the 160 EEG electrodes spaced evenly across the participant's scalp, which includes dreadlocks, and hair extensions applied by weaving, braiding, gluing, or clips-. unless the participants are willing to undo these styles prior to the EEG.
•Mini-Mental State Exam (MMSE) \<16 (telephone version); MMSE \<20 (in-person version)
•Prior chemotherapy for any malignancy
•Regularly taking opiates or take a daily, morning benzodiazepine or have taken a prn benzodiazepine prior to the assessment.
•Healthy Control Subject Exclusion Criteria
•Current or historical cancer diagnosis (a previous diagnosis of basal cell skin carcinoma is allowable)
•History of neurologic illnesses affecting cognition, (i.e., Traumatic Brain Injury with a loss of consciousness \>30 min., etc.) or severe psychiatric illness (i.e., schizophrenia, bipolar disorder, etc.);
•A hearing or visual deficit that impairs the ability to participate in the EEG tasks.