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NCT Number: NCT03137095

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

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.

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Key information

Conditions

Cancer Related Cognitive Difficulties Breast Cancer Female

Age range

21 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive testing

Other

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

Research Brain MRI

Other

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

Primary outcomes

  1. 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

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

Other outcomes

  1. Research Brain MRI

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sara Alberti

CONTACT

[email protected]

585-273-3998

Tyler Holler

CONTACT

[email protected]

585-273-2950

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
May 2, 2017
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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