Chemotherapy-Induced Cognitive Impairment (CICI)
|ClinicalTrials.gov Identifier: NCT01578083|
Recruitment Status : Completed
First Posted : April 16, 2012
Last Update Posted : February 26, 2013
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||28 participants|
|Observational Model:||Case Control|
|Official Title:||The Neurobiology of Chemotherapy-Induced Cognitive Impairment|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
With self-report cognitive impairment.
No Cognitive Impairment
Without self-report 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. ]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. ]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. ]As compared with the controls, the breast cancer patients will show increased mean diffusivity (MD) in frontal White Matter (WM).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|