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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01473680
• Other study ID #: 11-139
• Status: Terminated
• Phase: N/A
• First received: November 10, 2011
• Last updated: September 12, 2012
• Start date: November 2011
• Est. completion date: September 2012

Study information

• Verified date: September 2012
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 61 Years

Eligibility

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;

• Is fluent in English

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.

• 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)

• Regularly taking opiates or takes a daily, morning benzodiazepine or has taken a prn benzodiazepine prior to the assessment.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• EEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical Questionnaire
Participants will complete a medical/psychiatric history questionnaire, and a standardized battery of neuropsychological (NP) tests and psychological instruments. EEG recording will be made as participants engage in tasks of basic perceptual or pre-attentive processes and selective attention. Following chemotherapy (and a matched interval for the no-chemotherapy and healthy control groups), the standardized battery of NP tests, psychological instruments, and EEG will be repeated.
• EEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical Questionnaire
Participants will complete a medical/psychiatric history questionnaire, and a standardized battery of neuropsychological (NP) tests and psychological instruments. EEG recording will be made as participants engage in tasks of basic perceptual or pre-attentive processes and selective attention. Following chemotherapy (and a matched interval for the no-chemotherapy and healthy control groups), the standardized battery of NP tests, psychological instruments, and EEG will be repeated.
• EEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical Questionnaire
Participants will complete a medical/psychiatric history questionnaire, and a standardized battery of neuropsychological (NP) tests and psychological instruments. EEG recording will be made as participants engage in tasks of basic perceptual or pre-attentive processes and selective attention. Following chemotherapy (and a matched interval for the no-chemotherapy and healthy control groups), the standardized battery of NP tests, psychological instruments, and EEG will be repeated.

Locations

Country	Name	City	State
United States	Lincoln Hospital	Bronx	New York
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Ralph Lauren Center for Cancer Care and Prevention	New York	New York
United States	The City College of New York	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Lincoln Medical and Mental Health Center, Ralph Lauren Center for Cancer Care and Prevention, The City College of New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neuropsychologic (NP) features	through administration of NP and psychological instruments and EEG	2 years	No
Secondary	electrophysiologic features	through administration of NP and psychological instruments and EEG	2 years	No

External Links

•   Memorial Sloan-Kettering Cancer Center