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| Name | Class |
|---|---|
| Weill Medical College of Cornell University | OTHER |
| The City College of New York | OTHER |
| Brigham and Women's Hospital | OTHER |
| Biomedical Engineering Newark College of Engineering New Jersey Institute of Technology |
Patients with cancer often complain that their "mind does not seem to be clear." This can be due to stress, depression, anxiety, or physical problems caused by cancer or the treatments used to control symptoms. There are many purposes for this study; one of them is to learn about the effects of cancer treatments on the brain, and another is to identify useful tools to detect these effects. The results of this study may stimulate new research comparing different treatments to the current treatment so the researchers may learn how to treat symptoms more effectively and improve patient quality of life. We would also like to learn more about the effects chemotherapy may have on DNA.
This is a prospective, longitudinal study to examine time-dependent neurocognitive changes in patients with breast cancer receiving adjuvant chemotherapy. This study will assess chemotherapy-induced cognitive dysfunction. The researchers will recruit patients with localized breast cancer undergoing adjuvant chemotherapy for the first time and will test the effects of chemotherapy on patients' cognitive function utilizing a standardized neuropsychological battery. Patients scheduled for chemotherapy will be given a battery of neuropsychological undergo MRI evaluation prior to beginning chemotherapy and one month following completion of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1, Non Cancer group | A noncancer control group (N=35), frequency matched on age (< 50 and ≥ 50) and education (less than college or some college and above) will also be recruited and evaluated with the same neuropsychological test battery on a schedule that matches the inter-test interval of the patients. |
| |
| 2 Breast Cancer Patients Scheduled for chemotherapy | We will recruit patients with localized breast cancer undergoing adjuvant chemotherapy for the first time and will test the effects of chemotherapy will be given a battery of neuropsychological tests and an MRI evaluation prior to beginning chemotherapy and approximately one month (plus/minus 4 weeks) following completion of treatment. |
| |
| 3 Breast Cancer Patients Not Scheduled for Chemotherapy | We will recruit patients with localized breast cancer not undergoing adjuvant chemotherapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires, MRI, Comet assay and Cell senescence | Behavioral | Neuropsychological and psychological testing MRI, Comet assay and Cell senescence |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate changes in cognitive performance pre- to post-chemotherapy in breast cancer patients. | approximately 4 to 6 months from baseline, depending on chemotherapy regimen |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate associations between changes in frontal cortex and hippocampal volumes and activation patterns and changes in neuropsychological test performance. | 4 to 6 months | |
| To evaluate the relationship between change in level of oxidative DNA damage markers of cell senescence (Telomere attrition) and changes in volume and activation patterns in prefrontal cortex and hippocampus. |
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Inclusion Criteria:
Exclusion Criteria:
Healthy Control Inclusion Criteria:
Healthy Control Exclusion Criteria:
-Participant has Documented evidence of severe cognitive compromise (Blessed- Orientation Memory Cognition Test score > 11
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Potential subjects for the study will be identified MSKCC's clinic.
Healthy control group participants will be recruited through advertisements and flyers which will be available/advertised in the community. Health control participants will also be recruited by asking survivors if they have a friend who might want to volunteer for the study.
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| Name | Affiliation | Role |
|---|---|---|
| Tim Ahles, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| UNKNOWN |
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blood
|
| Questionnaires, MRI, Comet assay and Cell senescence | Behavioral | Neuropsychological and psychological testing MRI, Comet assay and Cell senescence |
|
|
| Questionnaires, MRI, Comet assay and Cell senescence | Behavioral | Neuropsychological and psychological testing, MRI, Comet assay and Cell senescence |
|
|
| 4 to 6 months |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D009682 | Magnetic Resonance Spectroscopy |
| D020552 | Comet Assay |
| D016922 | Cellular Senescence |
| D000073219 | Memory and Learning Tests |
| D009483 | Neuropsychological Tests |
| C000708228 | 2-cyclohexylidenhydrazo-4-phenyl-thiazole |
| D015337 | Multicenter Studies as Topic |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D004587 | Electrophoresis, Agar Gel |
| D004586 | Electrophoresis |
| D055664 | Electrochemical Techniques |
| D009152 | Mutagenicity Tests |
| D005821 | Genetic Techniques |
| D018675 | Toxicity Tests |
| D002468 | Cell Physiological Phenomena |
| D000375 | Aging |
| D048788 | Growth and Development |
| D010829 | Physiological Phenomena |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
| D016020 | Epidemiologic Study Characteristics |
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