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Clinical Trial NU 12B08

Title
Hippocampal Predictors of Cognitive Impairment (HippoPCI) in Breast Cancer Patients
Principal Investigator
Lei Wang
Details
  • Status: Accepting New Patients
  • Study Type: Observation, QOL
  • Protocol No:.NU 12B08
Purpose
The purpose of this study is to improve our understanding of differences in size, shape and activity of a variety of brain areas that can occur in women with breast cancer undergoing adjuvant chemotherapy or hormonal therapy, and how these brain areas are related to the development of mild mental impairment as the results of these treatments. This study involves obtaining pictures of the brain’s size, shape and activity using a Magnetic Resonance Imaging (MRI) device, a machine that uses a powerful magnet to obtain this information without using any radiation. This procedure has been used safely with humans in many different studies.
Overview
Participants are being asked to take part in a research study focused on predicting the onset of treatment-related mild mental impairment (i.e., MCI – subtle complaints that are noticeable in laboratory tests but otherwise do not interfere with daily activities) in women with breast cancer at Northwestern University Feinberg School of Medicine (NUFSM). Participants will be asked to come in for two visits at Northwestern University Department of Psychiatry and Behavioral Sciences and Northwestern University Feinberg School of Medicine’s Center for Translational Imaging (NUFSM CTI). These facilities are within several blocks of each other and are located at: Arkes Family Pavilion 676 North Saint Clair Street 10th Floor Chicago, IL 60611 and 710 N. Fairbanks Olson Pavilion, Lower Concourse Room 0-300 Chicago, IL 60611 This study will last for 1 year. Participants will be asked to sign a consent form and will have testing and procedures performed. These tests and procedures are done solely for the purposes of this study.
Eligibility
Some of the eligibility criteria include:
  • Participants must be female, within the age range of 40-70
  • Participants must be breast cancer or DCIS patients without brain metastasis receiving chemotherapy and/or hormonal therapy
  • Participants must be breast cancer patients receiving radiation therapy or no therapy
  • Participants must be cognitively healthy individuals
Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Description of Treatment
During this study we will measure several things at two time points: baseline (a.k.a. time zero or the time of your first visit) and 1 year after baseline. If participants are in the patient group, the baseline visit is at a point within several months of when treatment would start. There are a total of two visits over the course of participation (baseline and 1 year). Each visit will last about 4 hours, during which the following procedures and assessments will be performed: 1. Assessments of depression and anxiety - Since certain levels of depression and anxiety could affect cognitive test performance, a study clinician will conduct interviews to obtain information about any clinical depression and anxiety participants may have and the severity of any symptoms that they are experiencing now. The study clinician will also discuss any current medications being taken. 2. Neuropsychological assessment of cognition - This study includes a series of tasks that are designed to assess learning and memory, processing speed, and executive function skills. These tasks will involve reading and remembering words, looking at pictures of objects and designs, writing and drawing. These tasks will take a little over 1 hour and can be interrupted for breaks. 3. MRI/fMRI - This study uses magnetic resonance imaging (MRI) to look at the brain. Structural MRI is a type of scan that uses magnetic fields and radio waves to make a picture of the brain size and shape. Functional MRI is a type of brain scan that uses magnetic fields and radio waves to make an image of changes in blood flow in your brain while certain tasks are performed. 4. Questionnaires on depression, anxiety, well-being, fatigue, pain, cognition This study includes simple questionnaires on self-assessments of depression, anxiety, well-being, fatigue, pain, and cognition. These questionnaires may be completed at home if preferred. Because nutritional supplements, physical activity, and cognitive training games (e.g., Sudoku) may influence cognitive function, we may also collect brief information on them.
Contact
Clinical Trials Recruitment Nurse
Robert H. Lurie Comprehensive Cancer Center
312.695.1102
cancertrials@northwestern.edu

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last updated: 24-Jun-17 09:00 PM

 

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