Evaluating cognitive decline in older breast cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the impact of systemic therapy on cognitive function in older women diagnosed with breast cancer. It will explore changes in cognitive domains and quality of life, while also examining how genetic factors, inflammatory markers, sleep, and physical measures influence cognitive outcomes. The study is being conducted across multiple national sites, including prominent cancer centers, to gather a diverse patient population. By focusing on older patients, this research seeks to fill a gap in understanding the cognitive effects of cancer treatment in this demographic.

Why it matters

Who can join: the full rules

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

Where it's running

• Georgetown University
  Washington D.C., District of Columbia, United States Recruiting

Study contacts

• Principal investigator: Jeanne Mandelblatt — Lombardi Comprehensive Cancer Center
• Study coordinator: Jeanne Mandelblatt
• Email: mandelbj@georgetown.edu
• Phone: 2026870801

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.