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Chemotherapy-Induced Cognitive Impairment (CICI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01578083
First Posted: April 16, 2012
Last Update Posted: February 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Washington University Siteman Cancer Center
Barnes-Jewish Hospital
Information provided by (Responsible Party):
Jay F. Piccirillo, MD, Washington University
  Purpose

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
Cognitive Symptoms

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: The Neurobiology of Chemotherapy-Induced Cognitive Impairment

Further study details as provided by Jay F. Piccirillo, MD, Washington University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 28
Study Start Date: April 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cognitive Impairment
With self-report cognitive impairment.
No Cognitive Impairment
Without self-report cognitive impairment.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Breast cancer surviviors from Washington University's Siteman Cancer Center and from community at large.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01578083


Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Jay F. Piccirillo, MD
Washington University Siteman Cancer Center
Barnes-Jewish Hospital
Investigators
Principal Investigator: Jay F. Piccirillo, MD Washington University School of Medicine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jay F. Piccirillo, MD, Professor, Washington University
ClinicalTrials.gov Identifier: NCT01578083     History of Changes
Other Study ID Numbers: 201203045
First Submitted: April 12, 2012
First Posted: April 16, 2012
Last Update Posted: February 26, 2013
Last Verified: April 2012

Keywords provided by Jay F. Piccirillo, MD, Washington University:
Chemotherapy
Breast Cancer
Cognitive Impairment
Chemo brain

Additional relevant MeSH terms:
Cognition Disorders
Neurobehavioral Manifestations
Neurocognitive Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms