David Spiegel
Intellectual Impairment in Women With Breast Cancer
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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: This clinical trial is studying intellectual impairment in women with breast cancer.
Recruiting Status:
Not yet recruitingStanford Recruiting Status:
Not yet recruitingCondition(s):
Intervention(s):
- Behavior: Cognitive Rehabilitation (open)
- Behavior: Neurofeedback Training (randomized)
Phase:
Phase 1Eligibility
Ages Eligible for Study:
40 years to 70 yearsGenders Eligible for Study:
FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
3.1.1 Primary, non-metastatic breast cancer and healthy controls.
3.1.2 BC/chemo: any prior therapies including hormone treatments, etc. are allowed. History of chemotherapy regimen is required but must have been completed at least 6 months prior to enrollment. Any chemotherapy regimen is allowed.
BC/no chemo: any prior therapies are allowed with the exception of chemotherapy.
BC/pre-chemo: any prior therapies are allowed with the exception of chemotherapy. Chemotherapy must be indicated and the patient must be at least 3 days prior to the start of any potentially neurotoxic chemo.
Healthy controls: N/A
3.1.4 Female participants age 40-75 years of all ethnicities who speak fluent English will be recruited.
3.1.5 There are no life expectancy restrictions.
3.1.6 ECOG and Karnofsky Performance Status 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.
Key Exclusion Criteria:
3.2.1 BC Groups: 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.
Healthy Controls: History of conditions or treatments that would affect the assessments (e.g. including premature birth, developmental delays, learning disabilities, severe psychiatric conditions, brain injury, stroke, Aricept, Ritalin, Synthroid, Haldol). Non-English speaking. Major sensory impairment (e.g. hearing loss, blindness) that would render assessments invalid. MRI contraindications (e.g. metallic implants or devices). See also section 4.2.1.
3.2.2 Participants currently involved in other cognitive rehabilitation or intervention programs or drug trials 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 neurobiologic 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 Cancer survivors will be included. Those who are HIV+ will not given the known effects of this condition on cognitive function which would confound the effects of anti-cancer treatments on cognitive outcome.
Additional Study Details
Official Title:
Assessment and Treatment of Cognitive Deficits in Breast CancerAnticipated start date:
1/12/2009Lead Sponsor:
Stanford UniversityCollaborator(s):
- NCI
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
EfficacyPrimary Outcomes:
- 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.
Secondary Outcomes:
- Obtain preliminary data in a subset of participants to explore the relationships between diurnal cortisol and EF function.
Total Number to be Enrolled:
180Total Number to be Enrolled at Stanford:
180More Information
Secondary ID(s):
- BRS0002
- CDR0000632926
- NCT00896324
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
9/1/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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