Mild Cognitive Impairment in Breast Cancer Patients

Completed

• Conditions: Breast Cancer; Cognitive Impairment

• Registration Number: NCT01949376
• Lead Sponsor: Northwestern University

Brief Summary

The purpose of this study is to improve our understanding of potential changes in size, shape and activity in some brain areas that can occur in women receiving different types of Breast Cancer therapy, and how these changes are related to the development of mild cognitive impairment as the result of these treatments.

Detailed Description

This study aims to identify neuroimaging biomarkers for predicting mild cognitive impairment (MCI) in breast cancer patients receiving adjuvant chemo and/or hormonal therapy by examining hippocampal-cortical neurocircuitry. Adjuvant therapies increase long-term survival, but produce changes in cognitive function in 30% (up to 70%) of women on average with breast cancer. Cognitive decline negatively impacts quality of life in patients and their supporters. Therefore, early identification of patients at risk for developing treatment-related cognitive impairment is needed to develop potential prevention or treatment options and prevent further decline. Our recent work demonstrates that patients receiving adjuvant hormonal treatment exhibit decline in cognition as soon as three months post treatment. Although neuroimaging studies have identified brain changes associated with chemotherapy ("chemo brain", no investigation has assessed the type and severity of such changes following hormonal therapy, nor has any study determined which individuals are at greatest risk for cognitive impairment.

Our central hypothesis is that measures of the hippocampal-cortical integrity can be used to predict cognitive decline, and changes of specific domains of cognitive performance in patients receiving adjuvant therapy over time will be related to changes in specific components of this circuitry over time.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-09-19
• Study First Submitted QC: 2013-09-19
• Study First Posted: 2013-09-24
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-01
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

Inclusion Criteria

• Female, within the age range of 40-70
• HT Patients - any stage of breast cancer without brain metastasis, will undergo hormonal therapy without chemotherapy
• CT and HT Patients - any stage of breast cancer without brain metastasis, will undergo chemotherapy and hormonal therapy
• CT Patients - any stage of breast cancer without brain metastasis, has undergone surgery prior to screening, will undergo chemotherapy without hormonal therapy
• RT or NT Patients - any stage of breast cancer without brain metastasis, will not undergo chemotherapy or hormonal therapy; may undergo radiation therapy or have no therapy
• Controls - cognitively normal on the basis of annual neuropsychological and research neurological examinations done as part of the Uniform Data Set (UDS), of the NIA Alzheimer's Disease Centers (ADC) program, recruited from the NU CNADC Clinical Core.
• All subjects must have given signed, informed consent prior to registration on study.

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Exclusion Criteria

• Individuals who report significant medical, neurologic, or psychiatric illness, including but not limited to:

• Major depression

• Schizophrenia

• ADHD

• Autism

• Alzheimer's disease

• Dementia

• Obsessive-compulsive disorder

• Post-traumatic stress disorder

• Individuals with an Inventory of Depressive Symptomatology - Self Report (IDS-SR) score of 30 or higher, since this level of depression could affect cognitive test performance.

• Brain surgery or head injury

  • Individuals reporting previous head injury
  • Individuals requiring neurosurgical procedures

• Ineligibility for MRI scanning, including but not limited to:

  • Individuals who have non-MRI compatible medical implants or devices
  • Individuals who have any potential metal in their bodies
  • Individuals who have claustrophobia
  • Individuals with permanent makeup

• Individuals reporting consumption of drugs that would affect cognition (neuropsychiatric or illicit)

• Individuals indicating a history of breast cancer will be excluded from the healthy control group

• Women who are pregnant or are planning to become pregnant during study.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rates of change in cognitive function from before treatment to after treatment initiation	approximately 6 months	Measured using a neuropsychological test battery

Secondary Outcome Measures

Name	Time	Method
Rates of change of brain function from before treatment to after treatment initiation	approximately 6 months	Measured using a functional MRI scan
Rates of change of brain structure from before treatment to after treatment initiation	approximately 6 months	Measured using structural MRI scan

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States