©2022 Stanford Medicine
Intellectual Impairment in Women With Breast Cancer
Trial ID: NCT00896324
RATIONALE: Breast cancer and its treatment may cause changes in a patient's ability to think, learn, and remember. Gathering information about a woman's genes, brain function, and personal history may help doctors learn more about the disease and plan the best treatment. PURPOSE: 1. To determine changes in brain function that occur following breast cancer chemotherapy. 2. To gain further understanding of the individual differences in brain function changes and recovery based on demographic, medical and treatment variables.
Assessment and Treatment of Cognitive Deficits in Breast Cancer
3.1.1 Primary, non-metastatic breast cancer
3.1.2 Newly diagnosed patients who have not yet begun treatment.
3.1.4 Female participants age 40-65 years of all ethnicities who speak fluent English will
3.1.5 There are no life expectancy restrictions.
3.1.6 Karnofsky Performance Status 70% minimum. ECOG will not be employed.
3.1.7 There are no requirements for marrow function. The brain must be free from gross
neuropathology and metastases in order to participate.
3.1.8 Ability to understand and the willingness to sign a written informed consent
3.2.1 History of cognitive, psychiatric or medical conditions prior or unrelated to cancer
diagnosis and/or known to significantly impact assessments (e.g. premature birth,
developmental delays, learning disabilities, severe psychiatric conditions, brain injury,
stroke). Non-English speaking. Major sensory impairment (e.g. hearing loss, blindness) that
would render assessments invalid. MRI contraindications (e.g. metallic implants or
devices). Distant metastases. See also section 4.2.1.
3.2.2 Participants currently involved in studies specifically aimed at improving cognitive
symptoms will be excluded.
3.2.3 Participants with significant co-morbid diseases known to significant impact
neuropsychological function such as Alzheimer's or Parkinson's will be excluded.
3.2.4 There are no known risks for allergic reactions to any of the study procedures.
3.2.5 Participants taking certain medications that affect neuropsychological and/or brain
function including Haldol, Aricept, Ritalin, etc. will be excluded. Most anti-depressants
are acceptable. Some anti-anxiety medications may not be. Each case will be individually
3.2.6 There are no other agent-specific exclusion criteria.
3.2.7 Pregnant individuals will be excluded as this is a contraindication for the 3 Tesla
research MRI scanner employed by this study but not because of the treatment programs per
se. Nursing individuals can enroll.
3.2.8 Patients who are HIV positive will be excluded given the known effects of this
condition on cognitive function which would confound the effects of anti-cancer treatments
on cognitive outcome.
behavioral: Cognitive Rehabilitation
behavioral: Active Neurofeedback Training
behavioral: Neurofeedback Training (placebo / Sham)
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office