Mild Cognitive Impairment in Breast Cancer Patients (HippoPCI)

April 1, 2020 updated by: Lei Wang, Northwestern University

Hippocampal Predictors of Cognitive Impairment (HippoPCI) in Breast Cancer Patients

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.

Study Overview

Status

Completed

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 Type

Observational

Enrollment (Actual)

84

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited from the following sites, all affiliated with Northwestern University Feinberg School of Medicine (NUFSM): a) outpatient facility at Galter Pavilion of Northwestern Medicine; b) Maggie Daley Center for Women's Cancer Care at Prentice Women's Hospital; and c) Lynn Sage Comprehensive Breast Cancer Center at Prentice Women's Hospital.

Participants will also be recruited a) via advertisement in local newspapers, craigslist, Robert H. Lurie Comprehensive Cancer Center (RHLCC) Cancer Survivorship Institute website, and at community programs that serve cancer patients, including hospitals and support groups; and b) from community educational events sponsored by RHLCC, Women's Health Research Institute, and Cognitive Neurology and Alzheimer's Disease Center (CNADC).

Description

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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
healthy, cognitively normal subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of change in cognitive function from before treatment to after treatment initiation
Time Frame: approximately 6 months
Measured using a neuropsychological test battery
approximately 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of change of brain structure from before treatment to after treatment initiation
Time Frame: approximately 6 months
Measured using structural MRI scan
approximately 6 months
Rates of change of brain function from before treatment to after treatment initiation
Time Frame: approximately 6 months
Measured using a functional MRI scan
approximately 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lei Wang, PhD, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

September 19, 2013

First Submitted That Met QC Criteria

September 19, 2013

First Posted (Estimate)

September 24, 2013

Study Record Updates

Last Update Posted (Actual)

April 3, 2020

Last Update Submitted That Met QC Criteria

April 1, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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