Inflammation-Induced CNS Glutamate During Breast Cancer Treatment

Completed

• Conditions: Breast Cancer

• Registration Number: NCT02421978
• Lead Sponsor: Emory University

Brief Summary

The purpose of this study is to try and provide data linking the impact of increased inflammatory cytokines as a result of chemotherapy and their relationship with increased levels of CNS glutamate and related behavioral and cognitive consequences in breast cancer patients. The investigators will use neuropsychiatric assessments, blood sampling and Magnetic Resonance Spectroscopy (MRS) to collect study data.

Detailed Description

Approximately 70% of women with breast cancer experience behavioral and/or cognitive symptoms during treatment with chemotherapy and approximately 30% of women continue to experience these symptoms months to years after treatment completion. There is mounting data to suggest that inflammation may be involved and indicate that chemotherapy-treated breast cancer patients exhibit higher inflammatory markers than non-chemotherapy-treated patients, and inflammatory markers including interleukin (IL)-6 and soluble tumor necrosis factor (sTNFR2) have been associated with chemotherapy-induced depression and fatigue.

Study Timeline

• Study First Submitted: 2015-04-16
• Study First Submitted QC: 2015-04-16
• Study First Posted: 2015-04-21
• Study Start: 2015-05
• Primary Completion: 2018-05-29
• Study Completion: 2018-05-29
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-30
• Last Update Posted: 2019-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 98

Inclusion Criteria

• Female breast cancer patients will have undergone surgery (lumpectomy or mastectomy) with or without neoadjuvant or adjuvant chemotherapy
• Age between 21-65 years

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Exclusion Criteria

• Taking trastuzumab

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognitive dysfunction	Baseline	Cognitive measures of processing speed, attention, executive function, memory and motivation will be assessed.
Ratio of Glutamate to Creatine	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	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).
Behavioral assessments	Baseline	Behavioral assessments will be done to assessed to measure depression and anxiety.

Trial Locations

Locations (1)

Emory University Department of Psychiatry and Behavioral Sciences; 🇺🇸 Atlanta, Georgia, United States