Evaluating cognitive decline in older breast cancer patients
Older Breast Cancer Patients: Risk for Cognitive Decline. The Thinking and Living With Cancer (TLC) Study
This study is trying to see how cancer treatment affects thinking and memory in older women with breast cancer and what other factors might play a role.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1700 (estimated) |
| Ages | 60 Years to 105 Years |
| Sex | Female |
| Sponsor | Georgetown University Academic / other |
| Drugs / interventions | rituximab, chemotherapy, methotrexate, cyclophosphamide, Cytoxan |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT03451383 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 60 and older who have been newly diagnosed with primary breast cancer and have not previously undergone chemotherapy or hormonal treatment.
Not a fit: Patients who are younger than 60 or those who have received prior chemotherapy or hormonal treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies that minimize cognitive decline in older breast cancer patients.
How similar studies have performed: While there has been preliminary work on cognitive decline in younger breast cancer patients, this study represents a novel approach focusing specifically on older patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Washington D.C., District of Columbia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.