No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
21 and older
Sex
Female
Study type
Observational
Participants needed
150 (estimated)
Sponsor
University of Rochester · Other
Who this trial is looking for
This trial is looking for women with breast cancer starting chemotherapy and women without cancer for comparison. Participants will take part in cognitive tests and provide blood samples over about 5 months.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with invasive non-metastatic breast cancer.
I am scheduled to start chemotherapy with Adriamycin and Cytoxan.
I can speak and read English.
I am 21 years or older.
I give written informed consent.
You may not be able to join if
I am currently hospitalized for a psychiatric illness.
I have a neurodegenerative disease.
I have any Central Nervous System disease.
I am scheduled to receive radiation treatment during chemotherapy.
I am colorblind.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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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 writt…
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
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