Inflammation-Induced CNS Glutamate During Breast Cancer Treatment
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|ClinicalTrials.gov Identifier: NCT02421978|
Recruitment Status : Completed
First Posted : April 21, 2015
Last Update Posted : August 1, 2019
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||98 participants|
|Official Title:||Inflammation-Induced CNS Glutamate During Breast Cancer Treatment|
|Study Start Date :||May 2015|
|Actual Primary Completion Date :||May 29, 2018|
|Actual Study Completion Date :||May 29, 2018|
Chemotherapy-treated breast cancer group
Female subjects with Stage I-III breast cancer treated with chemotherapy will complete the neuropsychiatric assessment battery, blood sampling, self-report forms and magnetic resonance spectroscopy (MRS) scans
Non-Chemotherapy-treated breast cancer group
Non-chemotherapy treated female subjects with Stage I-III breast cancer will complete the neuropsychiatric assessment battery, blood sampling, self-report forms and magnetic resonance spectroscopy (MRS) scans
Age and race-matched healthy women will complete the neuropsychiatric assessment battery, blood sampling, self-report forms and magnetic resonance spectroscopy (MRS) scans
- Ratio of Glutamate to Creatine [ Time Frame: Baseline ]Single voxel MRS (Magnetic Resonance Spectroscopy) scans will be done to determine the glutamate levels in the dACC (dorsal anterior cingulate cortex), basal ganglia and hippocampus and the glutamate/ creatine (Glu/Cr) ratio will be calculated.MRS utilizes a magnetic field to look at magnetic nuclei, which absorb and re-emit electromagnetic energy in the presence of the magnetic field. By looking at the peaks in the resultant spectra the structure and concentration of metabolites can be determined.
- Levels of peripheral blood markers of inflammation [ Time Frame: Baseline ]Peripheral blood samples will be analyzed for levels of plasma c-reactive protein (CRP), tumor necrosis factor (TNF) and its soluble receptors (sTNFR1 and 2), interleukin (IL)-1 beta and the IL-1 receptor antagonist, and IL-6 and its soluble receptor (sIL-6R).
- Cognitive dysfunction [ Time Frame: Baseline ]Cognitive measures of processing speed, attention, executive function, memory and motivation will be assessed.
- Behavioral assessments [ Time Frame: Baseline ]Behavioral assessments will be done to assessed to measure depression and anxiety.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02421978
|United States, Georgia|
|Emory University Department of Psychiatry and Behavioral Sciences|
|Atlanta, Georgia, United States, 30030|
|Principal Investigator:||Andrew H Miller, MD||Emory University|