Clinical trial NCT03137095: Effects of Chemotherapy on Cognitive Function in Breast Cancer Patients & Non-Cancer Control Subjects With Optional Sub-Study Research Brain MRI
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 type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer Related Cognitive Difficulties
Breast Cancer Female
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2017-05-02
Enrollment: 150
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female breast cancer patients with a diagnosis of invasive non-metastatic breast cancer (stage I -IIIC) and age-matched, health female participants

Brief 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 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.


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

Primary outcomes:
measure: Cognitive function (memory, concentration, attentiveness) will be assessed by computerized cognitive assessments and associated with inflammation and neurotoxicity markers
timeFrame: During chemotherapy and 1 month post-chemotherapy; Approximately 3 - 5 months
Secondary outcomes:
Other outcomes:
measure: Research Brain MRI
timeFrame: After 4 cycles Adriamycin/Cytoxan (each cycle of AC is 14 days) and within 1 month post additional chemotherapy treatment
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Michelle C. Janelsins, Ph.D.,M.P.H.
role: PRINCIPAL_INVESTIGATOR
References: