Chemotherapy-Induced Cognitive Impairment
Status: | Completed |
---|---|
Conditions: | Cognitive Studies |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | Any |
Updated: | 2/4/2013 |
Start Date: | April 2012 |
End Date: | December 2012 |
The Neurobiology of Chemotherapy-Induced Cognitive Impairment
The investigators overall research hypothesis is that systemic chemotherapy induces
structural changes in the white matter of the brain as demonstrated with Diffusion Tensor
Imaging (DTI) and functional changes in well-defined cortical neural networks as
demonstrated by resting-state functional connectivity MRI (rs-fcMRI). The investigators
believe these structural and functional changes are responsible for the cognitive symptoms
associated with chemotherapy-induced cognitive impairment (CICI).
The Specific Aim for this study is:
To assess the impact of chemotherapy on structural white matter as defined by DTI and
functional cognitive networks as defined by rs-fcMRI by comparing a sample of breast cancer
survivors with self-reported CICI to breast cancer survivors without CICI.
Hypothesis: Post-chemotherapy breast cancer patients with self-reported CICI will have
abnormal structural connections characterized by DTI-defined disruptions in fractional
anisotropy (FA) and mean diffusivity (MD) and abnormal functional connectivity characterized
by rs-fcMRI-defined disruptions in cognitive networks when compared to patients without
self-reported CICI.
Chemotherapy has been linked to cognitive impairments among breast cancer patients,
especially in the domains of executive function (planning and problem solving), attention,
learning, and information processing. The etiology of these chemotherapy-associated
impairments remains unknown, although recent neuroimaging studies suggest that disruption of
white matter integrity may play a role. With continued use of chemotherapy in breast cancer
patients, this study's novel use of functional neuroimaging will be significant to better
inform practitioners and patients of potential consequences to anticipate and serve as a
starting point in the development of therapeutic interventions.
Inclusion Criteria:
- Inclusion Criteria (Phase I and II):
- Participants must be females between 35 and 70 years of age.
- Participants must have been diagnosed with breast cancer and completed
chemotherapy,within the preceding 2 years.
- Participants must have completed their intended full course of chemotherapy
regimen at least 30 days prior to participation.
- Participants must have been diagnosed with invasive ductal or lobular BrCa
Stages I, II, or III (American Joint Committee on Cancer (AJCC) staging manual,
7th edition, 2010).
Inclusion Criteria (Phase II)
- Participants must be able to read, write, and speak English fluently.
- Participants must be able to provide a valid informed consent.
- Participants must have a life expectancy of greater than 6 months at the time they
are approached for enrollment.
- Cases - Those who self-report CICI and are in the 75th percentile of scores on the
Cognitive Failures Questionnaire (CFQ) and have a global rating of cognition response
of "Extremely Affected" or "Strongly Affected"
- Controls - Those whose CFQ scores are in the lowest 25th percentile and who report
that their daily life is not affected by cognitive impairment. Controls will be
selected so that they are age (within 5 years)-matched to a Case.
Exclusion Criteria:
- • Participants with prior cancer diagnoses of other sites with evidence of active
disease within the past year.
- Participants who have received skull-base radiation treatment within the past
year for any reason. Skull-base radiation may contribute to the symptoms of
CICI.
- Participants with active diagnoses of any acute or chronic brain-related
neurological conditions that can alter normal brain anatomy or function,
including Parkinson's disease, Multiple Sclerosis, Alzheimer's Disease, cerebral
infarcts, , history of brain tumor(s), epilepsy, or dementia.
- Must not have a history of traumatic brain injury (loss of consciousness for >
15 min.)
- Participants with implanted metal objects not compatible with MRI, electrodes,
pacemakers, intracardiac lines, or medication pumps.
- Participants who weigh over 350 pounds (weight limit on MRI machine).
- Participants with a history of claustrophobia that will preclude undergoing MRI.
- Participants with an inability to lie flat for MRI.
- Any medical condition the PI determines would render the study unsafe or not in
the best interest of the patient.
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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