Inflammation-Induced CNS Glutamate During Breast Cancer Treatment

Breast Cancer Clinical Trial

Official title:

Inflammation-Induced CNS Glutamate During Breast Cancer Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02421978
• Other study ID #: IRB00080062
• Secondary ID: 1R21MH105897
• Status: Completed
• Start date: May 2015
• Est. completion date: May 29, 2018

Study information

• Verified date: July 2019
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: May 29, 2018
• Est. primary completion date: May 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Inflammation

Locations

Country	Name	City	State
United States	Emory University Department of Psychiatry and Behavioral Sciences	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio of Glutamate to Creatine	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.	Baseline
Primary	Levels of peripheral blood markers of inflammation	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).	Baseline
Primary	Cognitive dysfunction	Cognitive measures of processing speed, attention, executive function, memory and motivation will be assessed.	Baseline
Primary	Behavioral assessments	Behavioral assessments will be done to assessed to measure depression and anxiety.	Baseline