Intellectual Impairment in Women With Breast Cancer

Completed · Not applicable · Has a placebo group

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00896324

Run by

Stanford University

People needed

50

Starts

2009-01-12

Expected to finish

2013-06-01

Last updated by the study team

2019-05-01

Who can join

Age: 40 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Stanford University School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

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