Chemotherapy-Induced Cognitive Impairment

NCT01578083 | Completed

• 1 other identifier: 201203045
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cognitive Symptoms

Keywords

Chemotherapy; Breast Cancer; Cognitive Impairment; Chemo brain

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Secondary Outcomes (2)

• rs-fcMRI-defined disruptions in cognitive cortical networks

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

• Changes in Mean Diffusivity (MD) in one or more white matter tracks

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

Study Arms (2)

Cognitive Impairment

With self-report cognitive impairment.

No Cognitive Impairment

Without self-report cognitive impairment.

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer surviviors from Washington University's Siteman Cancer Center and from community at large.

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jay F. Piccirillo, MD: lead
• Washington University Siteman Cancer Center: collaborator
• Barnes-Jewish Hospital: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Piccirillo JF, Hardin FM, Nicklaus J, Kallogjeri D, Wilson M, Ma CX, Coalson RS, Shimony J, Schlaggar BL. Cognitive impairment after chemotherapy related to atypical network architecture for executive control. Oncology. 2015;88(6):360-8. doi: 10.1159/000370117. Epub 2015 Feb 7.

  PMID: 25678046 DERIVED

MeSH Terms

Conditions

Neurobehavioral Manifestations; Breast Neoplasms; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jay F. Piccirillo, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 12, 2012
• First Posted: April 16, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 26, 2013

Record last verified: 2012-04

Locations

US (1)