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This research study evaluates the effect of chemotherapy on cognition (thinking) and the brain in people with breast cancer.
This study is being done to study effects of chemotherapy (cancer treatment) on the brain and cognition (thinking). "Chemo-brain" is a term sometimes used to refer to effects of chemotherapy on the brain and cognition (thinking).
This study is being done to test for "chemo-brain" in older adults with breast cancer treated with chemotherapy, and to identify people who are most likely to be affected. The investigators will look at thinking abilities and brain images before and after chemotherapy to see if it can help identify people at risk for cognitive side effects of the treatment, and to better understand effects of treatment on brain structure and function.
The investigators are looking for participants who have either been recently recently diagnosed breast cancer participant or a healthy volunteer.
What is involved in the study:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM 1 | Active Comparator | Breast cancer patients treated with chemotherapy
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| ARM 2 | Active Comparator | Non-treated breast cancer patient control
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| ARM 3 | Active Comparator | Healthy control subjects
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive, functional and subjective assessments | Other | Cognitive and functional assessments |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in cognitive performance scores | Baseline, immediately after completion of chemo, and 6 months after completion of chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between baseline amyloid accumulation in the brain and change in cognitive performance | Baseline, 6 months after completion of chemotherapy | |
| Correlation between baseline tau accumulation in the brain and change in cognitive performance | Baseline, 6 months after completion of chemotherapy |
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Inclusion Criteria:
Breast cancer patients treated with chemotherapy- Group 1 (experimental group)
Non-treated breast cancer patient controls- Group 2 (control group)
Healthy control subjects- Group 3 (control group)
Exclusion Criteria:
Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study:
In addition to exclusion criteria above, participants who exhibit any of the following conditions at screening will not be eligible for admission into imaging portion of the study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael W Parsons, PhD | Contact | 617-643-0282 | mwparsons@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael Parsons, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
No data are yet available
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| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D001943 | Breast Neoplasms |
| D000084202 | Chemotherapy-Related Cognitive Impairment |
| ID | Term |
|---|---|
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000085542 | Functional Status |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D000203 | Activities of Daily Living |
| D012046 | Rehabilitation |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| MRI | Device | Magnetic Resonance Imaging (MRI) Scan |
|
| PET Scan | Radiation | Positron Emission Tomography (PET) Scan |
|
| Correlation between change in tau accumulation in the brain (from baseline to 6 months after completion of chemotherapy) and change in cognitive performance (from baseline to 6 months after completion of chemotherapy) | Baseline, 6 months after completion of chemotherapy |
| Massachusetts General Hospital/North Shore Cancer Center | Recruiting | Salem | Massachusetts | 01970 | United States |
|
| D001941 |
| Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D060825 | Cognitive Dysfunction |
| D006304 | Health Status |
| D003710 | Demography |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |