Intellectual Impairment in Women With Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shelli Kesler, Stanford University
ClinicalTrials.gov Identifier:
NCT00896324
First received: May 7, 2009
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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.

Condition Intervention Phase
Breast Cancer
Behavioral: Cognitive Rehabilitation
Behavioral: Neurofeedback Training (randomized)
Behavioral: Neuropsychological testing and MRI assessments
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment and Treatment of Cognitive Deficits in Breast Cancer

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: March 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cognitive Rehabilitation
Subjects will complete a curriculum of cognitive exercises 30 minutes per day, 5 days per week for 6-weeks.
Behavioral: Cognitive Rehabilitation
Cognitive rehabilitation exercises: 30 minutes per day, 5 days per week for 6 weeks.
Behavioral: Neuropsychological testing and MRI assessments
Neurofeedback training: 2-3, 30 min training sessions.
Experimental: Active Neurofeedback
Neurofeedback training: 2-3, 30 min training sessions.
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.
Sham Comparator: Sham Neurofeedback
Neurofeedback training: 2-3, 30 min training sessions.
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.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00896324

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Shelli Kesler Stanford University
  More Information

No publications provided

Responsible Party: Shelli Kesler, Assistant Professor of Psychiatry and Behavioral Sciences, Stanford University
ClinicalTrials.gov Identifier: NCT00896324     History of Changes
Obsolete Identifiers: NCT00866931
Other Study ID Numbers: BRS0002, SU-04062009-2139, 14623
Study First Received: May 7, 2009
Last Updated: May 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Quality of life

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014