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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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 21 Years and Over
Gender Female
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03137095
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Rochester
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Michelle C. Janelsins, Ph.D.,M.P.H.
Principal Investigator Affiliation University of Rochester
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Cancer Related Cognitive Difficulties, Breast Cancer Female
Arms & Interventions

Arms

: Breast Cancer Patient Participants

Female breast cancer patients receiving chemotherapy

: Healthy, age-matched, female participants

Healthy, female, age-matched participants

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Rochester, Rochester, New York

Status

Recruiting

Address

University of Rochester

Rochester, New York, 14642

Site Contact

Sara Alberti

[email protected]

585-273-3998

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