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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years and older
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws, MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "It involves a research brain MRI at Assessment 4.5 and cognitive testing and another research brain MRI at Assessment 6."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at thinking and memory problems during breast cancer chemotherapy and what changes in the body may cause them. It compares women newly diagnosed with breast cancer who are about to start chemotherapy with women of similar ages who have not had cancer. An optional part of the study includes brain MRI scans.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • All participants: Be a woman age 21 or older.
  • All participants: Be able to speak and read English.
  • All participants: Give written consent to join the study.
  • Breast cancer group: Have invasive breast cancer, stage I–IIIC, that has not spread to distant parts of the body.
  • Breast cancer group: Be scheduled to start chemotherapy with Adriamycin and Cytoxan.
  • Breast cancer group: Have never had chemotherapy.
  • Comparison group: Be within 5 years of the age of a participant receiving chemotherapy.
  • Optional brain scan study: Pass the center’s MRI safety screening.

Who can't join

  • All participants: Be in the hospital now, or have been hospitalized within the past year, for a mental health illness.
  • All participants: Have a disease that damages the brain over time, such as Alzheimer’s or Parkinson’s disease.
  • All participants: Have a disease of the brain or spinal cord, such as a movement disorder or multiple sclerosis.
  • All participants: Have had a stroke or TIA (a brief stroke-like event) within the past year, or still have symptoms from an older stroke or TIA.
  • All participants: Be colorblind.
  • Breast cancer group: Be scheduled to receive radiation treatment during chemotherapy.
  • Comparison group: Have ever been diagnosed with cancer or received chemotherapy.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

NY