Know Cancer

forgot password

The Neurobiology of Chemotherapy-Induced Cognitive Impairment

35 Years
70 Years
Not Enrolling
Cognitive Symptoms

Thank you

Trial Information

The Neurobiology of Chemotherapy-Induced 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.

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

- 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.

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Cross-Sectional

Outcome Measure:

Changes in fractional anisotropy (FA) in one or more white matter tracts.

Outcome Description:

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.

Outcome Time Frame:

post-chemotherapy. One time measure within one year of final dose of chemotherapy.

Safety Issue:


Principal Investigator

Jay F. Piccirillo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine


United States: Institutional Review Board

Study ID:




Start Date:

April 2012

Completion Date:

December 2012

Related Keywords:

  • Cognitive Symptoms
  • Chemotherapy
  • Breast Cancer
  • Cognitive Impairment
  • Chemo brain
  • Cognition Disorders
  • Neurobehavioral Manifestations



Washington University School of Medicine Saint Louis, Missouri  63110