Risk of Cognitive Decline in Older Patients With Newly Diagnosed Stage 0-III Breast Cancer
This research trial studies the risk of cognitive decline in older patients with newly diagnosed stage 0-III breast cancer. Learning about the effects of systemic therapy on cognition may help doctors plan cancer treatments.
Inclusion Criteria
- CANCER PATIENTS:
- Diagnosis of a new primary histological confirmed breast cancer
- American Joint Committee on Cancer (AJCC) stages 0-3 or planning on undergoing neoadjuvant therapy
- CANCER PATIENTS AND CONTROLS:
- 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 Criteria
- Participant report of a history of formal diagnosis of neurodegenerative disorders that affect cognition (i.e. Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, dementia, seizure disorders, etc.)
- Participant report of surgery on the brain for any reason (cancerous or non-cancerous tumors, subdural hematomas, arteriovenous [AV] malformations, increased intracranial pressure, etc.)
- Participant report of a history of stroke (with the exception of transient ischemic attack [TIA] if >= 1 year ago)
- Participant report of human immunodeficiency (HIV)/acquired immunodeficiency syndrome (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 (Diagnostic and Statistical Manual of Mental Disorders [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 magnetic resonance imaging (MRI) safe * Participant cannot have any type of implanted electrical device
Additional locations may be listed on ClinicalTrials.gov for NCT03451383.
Locations matching your search criteria
United States
District of Columbia
Washington
Florida
Tampa
Indiana
Indianapolis
New Jersey
Hackensack
New York
New York
PRIMARY OBJECTIVES:
I. Conduct assessments every 12 months up to approximately 60-month to identify trajectories of longitudinal cognitive function (normal, phase shift, or accelerated aging).
II. Identify risk factors for decline in cognitive function in the period up to approximately 60 months post-enrollment.
III. Assess inflammation as a potential mechanism for cognitive decline.
IV. To use neuroimaging to assess structural and functional effects of cancer treatment.
OUTLINE:
Patients participate in 55-minute neuropsychological tests and telephone interviews assessing cognitive function at baseline, 12 months, and 24 months. Samples of blood or saliva are collected to assess APOE polymorphisms at baseline.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationMedStar Georgetown University Hospital
Principal InvestigatorJeanne Susan Mandelblatt
- Primary ID2008-363
- Secondary IDsNCI-2013-00927
- ClinicalTrials.gov IDNCT03451383