Cancer Related Cognitive DifficultiesNCT03137095
Effects of Chemotherapy on Cognitive Function in Breast Cancer Patients & Non-Cancer Control Subjects With Optional Sub-Study Research Brain MRI
An observational study of Cancer Related Cognitive Difficulties and Breast Cancer Female, run by University of Rochester at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer Related Cognitive Difficulties, Breast Cancer Female
- What is being tested?
- Cognitive testing and Research Brain MRI
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2017to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female breast cancer patients with a diagnosis of invasive non-metastatic breast cancer (stage I -IIIC) and age-matched, health female participants
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Rochester
Rochester, New York, 14642
Sara Alberti, 585-273-3998, Sara_Alberti@urmc.rochester.edu
Tyler Holler, 585-273-2950, Tyler_Holler@urmc.rochester.edu
About this study
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
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.
- Being tested
- Cognitive testing, Research Brain MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive testingOther
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 MRIOther
Optional sub-study participation includes undergoing research brain MRI to obtain structural and functional brain images at Assessment 4.5 and 6.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer Patient Participants | Female breast cancer patients receiving chemotherapy Receives: Other: Cognitive testing; Other: Research Brain MRI | |
| Healthy, age-matched, female participants | Healthy, female, age-matched participants Receives: Other: Cognitive testing; Other: Research Brain MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function (memory, concentration, attentiveness) will be assessed by computerized cognitive assessments and associated with inflammation and neurotoxicity markers
Change scores from baseline will be computed for each cognitive measure as well as each mechanistic marker
Measured: During chemotherapy and 1 month post-chemotherapy; Approximately 3 - 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start20 Feb 2017
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer Related Cognitive DifficultiesStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Janelsins, PhD, MPH, University of Rochester
- Investigators
- Michelle C. Janelsins, Ph.D.,M.P.H., Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137095
- Sponsor's protocol ID
- 54027
- Status last verified
- Apr 2026
- First submitted
- 27 Apr 2017
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03137095
- Acronym / sponsor ID
- 54027
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 2 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Patient Participants | – | Other: Cognitive testing, Other: Research Brain MRIFemale breast cancer patients receiving chemotherapy |
| Healthy, age-matched, female participants | – | Other: Cognitive testing, Other: Research Brain MRIHealthy, female, age-matched participants |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female breast cancer patients with a diagnosis of invasive non-metastatic breast cancer (stage I -IIIC) and age-matched, health female participants
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive testingcomputerized and paper-based cognitive tests that assess memory, executive function, processing speed and concentration performed at Assessments 1, 3, 4.5 \& 5. | Other | Breast Cancer Patient Participants, Healthy, age-matched, female participants |
| Research Brain MRIOptional sub-study participation includes undergoing research brain MRI to obtain structural and functional brain images at Assessment 4.5 and 6. | Other | Breast Cancer Patient Participants, Healthy, age-matched, female participants |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michelle C. Janelsins, Ph.D.,M.P.H. principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Related Cognitive Difficulties and Breast Cancer Female, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Alberti (585-273-3998, Sara_Alberti@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.