Trials / Completed
CompletedNCT01578083
Chemotherapy-Induced Cognitive Impairment
The Neurobiology of Chemotherapy-Induced Cognitive Impairment
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 28 (actual)
- Sponsor
- Jay F. Piccirillo, MD · Academic / Other
- Sex
- Female
- Age
- 35 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Timeline
- Start date
- 2012-04-01
- Primary completion
- 2012-12-01
- Completion
- 2012-12-01
- First posted
- 2012-04-16
- Last updated
- 2013-02-26
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01578083. Inclusion in this directory is not an endorsement.