Status:
RECRUITING
Older Breast Cancer Patients: Risk for Cognitive Decline
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
Memorial Sloan Kettering Cancer Center
Indiana University
Conditions:
Cancer, Breast
Age-related Cognitive Decline
Eligibility:
FEMALE
60-105 years
Brief Summary
The goal of this study is to evaluate the impact of systemic therapy on cognition in older breast cancer patients, explore change in APE, LM and Cognition domains, measure associations between cogniti...
Detailed Description
Cancer is the leading cause of death in the US and breast cancer is the second most common cancer among women in our country. Older women (women 60 and older) presently account for nearly half of all ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- For cancer patients, eligibility includes:
- being female
- Age 60+ at diagnosis of a new primary histological confirmed adenocarcinoma breast cancer
- AJCC stages 0-3 or planning neoadjuvant therapy
- In the judgment of the consenting professional, able to communicate well enough in English through verbal and written communication to complete the study assessments and provide informed consent
- If currently taking psychoactive medications (including, but not limited to anticonvulsants, antidepressants, and anxiolytics), dose must have been stable at least two months prior to enrollment.
- Participant report of no previous or current chemotherapy or hormonal treatment use (anastrazole, exemestane, etc.) This does not include hormonal replacement therapy, synthetic thyroid hormones, etc.
- For controls, eligibility includes:
- being female
- Age 60+
- In the judgment of the consenting professional, able to communicate well enough in English through verbal and written communication to complete the study assessments and provide informed consent
- If currently taking psychoactive medications (including, but not limited to anticonvulsants, antidepressants, and anxiolytics), dose must have been stable at least two months prior to enrollment.
- Exclusion:
- We apply the same exclusion criteria for patients and controls.
- Participant report of a history of formal diagnosis of neurological problems (i.e. Alzheimer's disease, Parkinson's disease, Multiple Sclerosis, Dementia, Seizure Disorders, brain tumors, etc.)
- Participant report of surgery on the brain for any reason (cancerous or non-cancerous tumors, subdural hematomas, AV malformations, increased intracranial pressure, etc.)
- Participant report of a history of stroke (with the exception of TIA if ≥1 year ago)
- Participant report of HIV/AIDS
- Participant report of moderate to severe head trauma (loss of consciousness \> 60 min or with evidence of structural brain changes on imaging)
- History of major psychiatric disorder (DSM-IV Axis 1) (i.e. major depressive disorder (untreated or poorly treated), bipolar disorders, schizophrenia, or substance abuse disorders (self-reported and/or stated in medical record).
- Participant report of a history of prior breast or other cancer with the exception of non-melanoma skin cancer. An exception for cases only: women who completed treatment for a previous cancer at least 5 years ago and have not undergone any chemotherapy or hormonal therapy. This previous cancer cannot be breast cancer.
- Participant report of previous or current chemotherapy or hormonal therapy use
- Participant use of methotrexate (Amethopterin, Rhematrex, Trexall) or rituximab (Rituxin) for rheumatoid arthritis, psoriasis or Crohn's disease, or cyclophosphamide (Cytoxan, Neosar) for Lupus.
- Visual or hearing impairment that would preclude ability to complete interviews or neuropsychological testing, such as significant macular degeneration or being unable to correct hearing with hearing aides
- Non-English speaking
- To participate in the optional neuroimaging portion of the study:
- Participant cannot be claustrophobic Participant cannot have a pacemaker, aneurysm clip or other implants that are not MRI safe Participant cannot have any type of implanted electrical device
Exclusion
Key Trial Info
Start Date :
August 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 30 2025
Estimated Enrollment :
1700 Patients enrolled
Trial Details
Trial ID
NCT03451383
Start Date
August 1 2010
End Date
April 30 2025
Last Update
March 11 2025
Active Locations (1)
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1
Georgetown University
Washington D.C., District of Columbia, United States, 20007