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Assessment and Treatment of Cognitive Deficits in Breast Cancer

Phase 1
40 Years
65 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Assessment and Treatment of Cognitive Deficits in Breast Cancer

Inclusion Criteria:

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
be recruited.

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

Exclusion Criteria:

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Examine the effectiveness of a cognitive rehabilitation program for improving executive function (EF) deficits and a neurofeedback training program for preventing or lessening EF impairments in women with Breast Cancer..

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Shelli Kesler

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Institutional Review Board

Study ID:




Start Date:

March 2012

Completion Date:

August 2014

Related Keywords:

  • Breast Cancer
  • Quality of life
  • Breast Neoplasms



Stanford University School of Medicine Stanford, California  94305-5317