Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mild Cognitive Impairment in Breast Cancer Patients (HippoPCI)

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.
 
ClinicalTrials.gov Identifier: NCT01949376
Recruitment Status : Completed
First Posted : September 24, 2013
Last Update Posted : April 3, 2020
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Lei Wang, Northwestern University

Tracking Information
First Submitted Date September 19, 2013
First Posted Date September 24, 2013
Last Update Posted Date April 3, 2020
Study Start Date June 2013
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 16, 2016)
Rates of change in cognitive function from before treatment to after treatment initiation [ Time Frame: approximately 6 months ]
Measured using a neuropsychological test battery
Original Primary Outcome Measures
 (submitted: September 19, 2013)
Rates of change in cognitive function from baseline to one year [ Time Frame: Baseline to one year ]
Measured using a neuropsychological test battery
Change History
Current Secondary Outcome Measures
 (submitted: June 16, 2016)
  • Rates of change of brain structure from before treatment to after treatment initiation [ Time Frame: approximately 6 months ]
    Measured using structural MRI scan
  • Rates of change of brain function from before treatment to after treatment initiation [ Time Frame: approximately 6 months ]
    Measured using a functional MRI scan
Original Secondary Outcome Measures
 (submitted: September 19, 2013)
  • Rates of change of brain structure from baseline to one year [ Time Frame: Baseline to one year ]
    Measured using structural MRI scan
  • Rates of change of brain function from baseline to one year [ Time Frame: Baseline to one year ]
    Measured using a functional MRI scan
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Mild Cognitive Impairment in Breast Cancer Patients
Official Title Hippocampal Predictors of Cognitive Impairment (HippoPCI) in Breast Cancer Patients
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).

Condition
  • Breast Cancer
  • Cognitive Impairment
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 1, 2020)
84
Original Estimated Enrollment
 (submitted: September 19, 2013)
120
Actual Study Completion Date December 31, 2019
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01949376
Other Study ID Numbers 1R01NR014182-01( U.S. NIH Grant/Contract )
1R01NR014182-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Lei Wang, Northwestern University
Study Sponsor Northwestern University
Collaborators National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Lei Wang, PhD Northwestern University
PRS Account Northwestern University
Verification Date April 2020