Effects of Chemotherapy on Cognitive Function in Breast Cancer Patients & Non-Cancer Control Subjects With Optional Sub-Study Research Brain MRI

Sponsor
University of Rochester (Other)
Overall Status
Recruiting
CT.gov ID
NCT03137095
Collaborator
(none)
150
1
82.3
1.8

Study Details

Study Description

Brief Summary

Study is enrolling newly diagnosed breast cancer patients about to start chemotherapy and age-matched control participants. The investigator is trying to better understand the prevalence of cognitive difficulties in cancer patients receiving chemotherapy compared to the general population as well as what biological mechanisms may play a role in the development of these difficulties. Patients will be asked to complete six assessments over the course of approximately 5 months. Assessments 1,3, 4.5 and 5 include computerized and paper and pencil cognitive testing as well as blood draws. Assessments 2 and 4 only involve the collection of a blood sample. An optional sub study is offered after Assessment 1. It involves a research brain MRI at Assessment 4.5 and cognitive testing and another research brain MRI at Assessment 6.

Condition or Disease Intervention/Treatment Phase
  • Other: Cognitive testing
  • Other: Research Brain MRI

Study Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Longitudinal Pilot Mechanistic Study of the Effects of Chemotherapy on Cognitive Function in Breast Cancer Patients and Non-Cancer Control Participants - Optional Sub-Study: Research Brain MRI
Actual Study Start Date :
Feb 20, 2017
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Breast Cancer Patient Participants

Female breast cancer patients receiving chemotherapy

Other: Cognitive testing
computerized and paper-based cognitive tests that assess memory, executive function, processing speed and concentration performed at Assessments 1, 3, 4.5 & 5.

Other: Research Brain MRI
Optional sub-study participation includes undergoing research brain MRI to obtain structural and functional brain images at Assessment 4.5 and 6.

Healthy, age-matched, female participants

Healthy, female, age-matched participants

Other: Cognitive testing
computerized and paper-based cognitive tests that assess memory, executive function, processing speed and concentration performed at Assessments 1, 3, 4.5 & 5.

Other: Research Brain MRI
Optional sub-study participation includes undergoing research brain MRI to obtain structural and functional brain images at Assessment 4.5 and 6.

Outcome Measures

Primary Outcome Measures

  1. Cognitive function (memory, concentration, attentiveness) will be assessed by computerized cognitive assessments and associated with inflammation and neurotoxicity markers [During chemotherapy and 1 month post-chemotherapy; Approximately 3 - 5 months]

    Change scores from baseline will be computed for each cognitive measure as well as each mechanistic marker

Other Outcome Measures

  1. Research Brain MRI [After 4 cycles Adriamycin/Cytoxan (each cycle of AC is 14 days) and within 1 month post additional chemotherapy treatment]

    MRI brain imaging to obtain structural and connectivity data via fMRI (brain function), T1MRI (brain structure) and DTI (white matter related microstructure in brain) to determine if there are changes within the brain related to cognitive performance, symptoms, immune and other biologic factors

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria, Breast Cancer Patient Participants:
  • Females with a diagnosis of invasive non-metastatic breast cancer (stage I-IIIC)

  • Scheduled to begin a course of chemotherapy with Adriamycin and Cytoxan

  • Chemotherapy naïve

  • Able to speak and read English

  • 21 years or older

  • Give written informed consent

Exclusion Criteria, Breast Cancer Patient Participants:
  • Must not be currently hospitalized or have been hospitalized within the last year for a psychiatric illness

  • Must not be diagnosed with a neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease)

  • Must not have any Central Nervous System disease (e.g., movement disorder, multiple sclerosis)

  • Subjects could have had a TIA (transient ischemic attack) or stroke in the past if the TIA or stroke was greater than 1 year ago and the subject does not have any remaining symptoms

  • Must not be scheduled to receive concurrent radiation treatment while receiving chemotherapy.

  • Must not be colorblind

Inclusion Criteria, Control Participants:
  • Must be female and within 5 years of the age of the subject receiving chemotherapy

  • Able to speak and read English

  • Give written informed consent

  • 21 years or older

Exclusion Criteria, Control Participants:
  • Must not be currently hospitalized or have been hospitalized within the last year for a psychiatric illness

  • Must not be diagnosed with a neurodegenerative disease (e.g. Alzheimer's disease, Parkinson's disease)

  • Must not have Central Nervous System disease (e.g., movement disorder, multiple sclerosis)

  • Subjects could have had a TIA (transient ischemic attack) or stroke in the past if the TIA or stroke was greater than 1 year ago and the subject does not have any remaining symptoms

  • Must not have been diagnosed with cancer or previously have received chemotherapy

  • Must not be colorblind

For optional sub-study: MR safety assessed via Rochester Center for Brain Imaging Magnetic Resonance (MR) Safety Screening Form to confirm eligibility to participate

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Rochester Rochester New York United States 14642

Sponsors and Collaborators

  • University of Rochester

Investigators

  • Principal Investigator: Michelle C. Janelsins, Ph.D.,M.P.H., University of Rochester

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michelle Janelsins, PhD, MPH, Assistant Professor, University of Rochester
ClinicalTrials.gov Identifier:
NCT03137095
Other Study ID Numbers:
  • 54027
First Posted:
May 2, 2017
Last Update Posted:
Feb 9, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 9, 2022