Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT03017560
Eligibility Criteria:
Inclusion Criteria:
* Women ages 65-90
* Chemotherapy treatment for early-stage (I, IIa, IIb, IIIa) breast cancer
* Post-menopausal
* High school education or greater
* Geographically available for followup assessment
* Native English speaker
* Normal or corrected to near-normal hearing and vision
Exclusion Criteria:
* Psychiatric history including past or current psychotic spectrum disorders (schizophrenia, bipolar disorder, major depressive disorder, dementia, schizoaffective disorder)
* Brain injury (e.g., stroke, heart attack, aneurysm, tumor, concussion, head trauma)
* Brain disease
* History of brain irradiation or surgery
* Current or past disease/disorder of the central nervous system or medical condition affecting cognitive functioning (e.g., chronic migraine, epilepsy or history of seizures, encephalitis, meningitis, multiple sclerosis, thyroid condition, Parkinson's, Alzheimer's, Huntington's disease)
* Active diagnosis of autoimmune or inflammatory disorder (e.g., systemic lupus erythematosus, rheumatoid arthritis, vasculitis, insulin-dependent diabetes, Crohn's disease, uncontrolled allergic reaction or asthma)
* History of other cancer, except for basal cell carcinoma
* Development of a second primary malignancy during the study
* Drug or alcohol abuse (i.e., more than 7 drinks per week)
* Chronic use of oral steroid medication
* Former (prior to early-stage breast cancer) intrathecal therapy, radiation therapy, chemotherapy, or any neoadjuvant chemotherapy
* Acquired or developmental speech, language, or learning disorders (e.g., aphasia, dyslexia, dysgraphia, auditory processing disorder, autism, developmental delay)
* Hormone replacement therapy, excluding vaginal estrogen
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
65 Years
Maximum Age:
90 Years
Study:
NCT03017560
Study Brief:
Protocol Section:
NCT03017560