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Inflammation-Induced CNS Glutamate During Breast Cancer Treatment

Inflammation-Induced CNS Glutamate During Breast Cancer Treatment

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02421978
Enrollment
98
Registered
2015-04-21
Start date
2015-05-31
Completion date
2018-05-29
Last updated
2019-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Cognitive dysfunction, Inflammation, Fatigue, Decreased motivation

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.

Interventions

None listed

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Emory University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 65 Years
Healthy volunteers
Yes

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

Exclusion criteria

* Taking trastuzumab

Design outcomes

Primary

MeasureTime frameDescription
Ratio of Glutamate to CreatineBaselineSingle 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 inflammationBaselinePeripheral 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 dysfunctionBaselineCognitive measures of processing speed, attention, executive function, memory and motivation will be assessed.
Behavioral assessmentsBaselineBehavioral assessments will be done to assessed to measure depression and anxiety.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026