Clinical Trials Directory

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.