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Recruiting NCT03137095

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

— Observational Cancer Related Cognitive Difficulties Breast Cancer Female

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cognitive testing, Research Brain MRI.
Who it may be relevant to
Registry conditions: Cancer Related Cognitive Difficulties, Breast Cancer Female. Basic parameters: from 21 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • University of Rochester — Rochester

Identifiers

NCT: NCT03137095 · 54027

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗