Intellectual Impairment in Women With Breast Cancer

This study is currently recruiting participants.
Verified May 2013 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00896324
First received: May 7, 2009
Last updated: May 28, 2013
Last verified: May 2013

May 7, 2009
May 28, 2013
March 2012
August 2013   (final data collection date for primary 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.. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Identify genetic and demographic predictors of cognitive impairment in women with Breast Cancer. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Determine the profile of cognitive-behavioral impairments in women with BC related to adjuvant chemotherapy. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • 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 BC.
  • Identify genetic and demographic predictors of cognitive impairment in women with BC.
  • Determine the profile of cognitive-behavioral impairments in women with BC related to adjuvant chemotherapy.
Complete list of historical versions of study NCT00896324 on ClinicalTrials.gov Archive Site
Not Provided
Obtain preliminary data in a subset of participants to explore the relationships between diurnal cortisol and EF function.
Not Provided
Not Provided
 
Intellectual Impairment in Women With Breast Cancer
Assessment and Treatment of Cognitive Deficits in Breast Cancer

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Breast Cancer
  • Behavioral: Cognitive Rehabilitation
    Cognitive rehabilitation exercises: 30 minutes per day, 5 days per week for 6 weeks.
  • Behavioral: Neurofeedback Training (randomized)
    Neurofeedback training: 2-3, 30 min training sessions.
  • Behavioral: Neuropsychological testing and MRI assessments
    Neurofeedback training: 2-3, 30 min training sessions.
  • Active Comparator: Cognitive Rehabilitation
    Subjects will complete a curriculum of cognitive exercises 30 minutes per day, 5 days per week for 6-weeks.
    Interventions:
    • Behavioral: Cognitive Rehabilitation
    • Behavioral: Neuropsychological testing and MRI assessments
  • Experimental: Active Neurofeedback
    Neurofeedback training: 2-3, 30 min training sessions.
    Interventions:
    • Behavioral: Neurofeedback Training (randomized)
    • Behavioral: Neuropsychological testing and MRI assessments
  • Sham Comparator: Sham Neurofeedback
    Neurofeedback training: 2-3, 30 min training sessions.
    Interventions:
    • Behavioral: Neurofeedback Training (randomized)
    • Behavioral: Neuropsychological testing and MRI assessments
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
August 2014
August 2013   (final data collection date for primary outcome measure)

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 document.

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 reviewed.

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.

Female
40 Years to 65 Years
No
Contact: Shelli Kesler, PhD (650) 723-0058 skesler@stanford.edu
United States
 
NCT00896324
BRS0002, SU-04062009-2139, 14623
Yes
Stanford University
Stanford University
Not Provided
Principal Investigator: Shelli Kesler Stanford University
Stanford University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP