Mild Cognitive Impairment in Breast Cancer Patients (HippoPCI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Northwestern University
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Lei Wang, Northwestern University
ClinicalTrials.gov Identifier:
NCT01949376
First received: September 19, 2013
Last updated: June 16, 2016
Last verified: June 2016
  Purpose
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.

Condition
Breast Cancer
Cognitive Impairment

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Hippocampal Predictors of Cognitive Impairment (HippoPCI) in Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Rates of change in cognitive function from before treatment to after treatment initiation [ Time Frame: approximately 6 months ] [ Designated as safety issue: No ]
    Measured using a neuropsychological test battery


Secondary Outcome Measures:
  • Rates of change of brain structure from before treatment to after treatment initiation [ Time Frame: approximately 6 months ] [ Designated as safety issue: No ]
    Measured using structural MRI scan

  • Rates of change of brain function from before treatment to after treatment initiation [ Time Frame: approximately 6 months ] [ Designated as safety issue: No ]
    Measured using a functional MRI scan


Estimated Enrollment: 120
Study Start Date: June 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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).

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01949376

Contacts
Contact: Jessica Berger, LCSW 312-503-4995 jessica.berger1@northwestern.edu
Contact: Melody Fairchild, M.A.T. 312-503-7071 m-fairchild@northwestern.edu

Locations
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Jessica Berger, LCSW    312-503-4995    jessica.berger1@northwestern.edu   
Contact: Melody Fairchild, M.A.T.    312-503-7071    m-fairchild@northwestern.edu   
Principal Investigator: Lei Wang, PhD         
Sponsors and Collaborators
Northwestern University
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Lei Wang, PhD Northwestern University
  More Information

Additional Information:
Responsible Party: Lei Wang, Assistant Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT01949376     History of Changes
Other Study ID Numbers: 1R01NR014182-01 
Study First Received: September 19, 2013
Last Updated: June 16, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
breast cancer
invasive ductal carcinoma
cognitive impairment
adjuvant therapy
hormone therapy
hormonal therapy
chemotherapy
chemo brain
MRI

Additional relevant MeSH terms:
Breast Neoplasms
Cognition Disorders
Mild Cognitive Impairment
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 23, 2016