Chemotherapy-Induced Cognitive Impairment (CICI)
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||The Neurobiology of Chemotherapy-Induced Cognitive Impairment|
- Changes in fractional anisotropy (FA) in one or more white matter tracts. [ Time Frame: post-chemotherapy. One time measure within one year of final dose of chemotherapy. ] [ Designated as safety issue: No ]As compared with the controls, the breast cancer patients will show decreased fractional anisotropy (FA) in the frontal and temporal white matter (WM) tracts and.
- rs-fcMRI-defined disruptions in cognitive cortical networks [ Time Frame: post-chemotherapy: post-chemotherapy. One time measure within one year of final dose of chemotherapy. ] [ Designated as safety issue: No ]As compared with the controls, the breast cancer patients will show decreased functional integrity of the default mode network [DMN], associated with memory; the dorsal and ventral attention networks [DAN/VAN], involved in attention; and the Cognitive/Control network, involved in executive decision-making
- Changes in Mean Diffusivity (MD) in one or more white matter tracks [ Time Frame: Post Chemotherapy: post-chemotherapy. One time measure within one year of final dose of chemotherapy. ] [ Designated as safety issue: No ]As compared with the controls, the breast cancer patients will show increased mean diffusivity (MD) in frontal White Matter (WM).
|Study Start Date:||April 2012|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
With self-report cognitive impairment.
No Cognitive Impairment
Without self-report cognitive impairment.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578083
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Jay F. Piccirillo, MD||Washington University School of Medicine|