Status:
COMPLETED
Intellectual Impairment in Women With Breast Cancer
Lead Sponsor:
Stanford University
Conditions:
Breast Cancer
Eligibility:
FEMALE
40-65 years
Phase:
NA
Brief Summary
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...
Detailed Description
This study aims to determine some of the genetic, neurobiologic and demographic factors that are associated with cognitive outcome following breast cancer (BC). Additionally, it aims to test novel beh...
Eligibility Criteria
Inclusion
- 1.1 Primary, non-metastatic breast cancer
- 1.2 Newly diagnosed patients who have not yet begun treatment.
- 1.4 Female participants age 40-65 years of all ethnicities who speak fluent English will be recruited.
- 1.5 There are no life expectancy restrictions.
- 1.6 Karnofsky Performance Status 70% minimum. ECOG will not be employed.
- 1.7 There are no requirements for marrow function. The brain must be free from gross neuropathology and metastases in order to participate.
- 1.8 Ability to understand and the willingness to sign a written informed consent document.
Exclusion
- 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.
- 2.2 Participants currently involved in studies specifically aimed at improving cognitive symptoms will be excluded.
- 2.3 Participants with significant co-morbid diseases known to significant impact neuropsychological function such as Alzheimer's or Parkinson's will be excluded.
- 2.4 There are no known risks for allergic reactions to any of the study procedures.
- 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 reviewed.
- 2.6 There are no other agent-specific exclusion criteria.
- 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.
- 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.
Key Trial Info
Start Date :
January 12 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00896324
Start Date
January 12 2009
End Date
June 1 2013
Last Update
May 1 2019
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305