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Inflammation-Induced CNS Glutamate During Breast Cancer Treatment

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ClinicalTrials.gov Identifier: NCT02421978
Recruitment Status : Active, not recruiting
First Posted : April 21, 2015
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
Andrew H Miller, 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.

Condition or disease
Breast Cancer

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 Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Inflammation-Induced CNS Glutamate During Breast Cancer Treatment
Study Start Date : May 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort
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
Control group
Age and race-matched healthy women will complete the neuropsychiatric assessment battery, blood sampling, self-report forms and magnetic resonance spectroscopy (MRS) scans



Primary Outcome Measures :
  1. 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.

  2. 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).

  3. Cognitive dysfunction [ Time Frame: Baseline ]
    Cognitive measures of processing speed, attention, executive function, memory and motivation will be assessed.

  4. Behavioral assessments [ Time Frame: Baseline ]
    Behavioral assessments will be done to assessed to measure depression and anxiety.


Biospecimen Retention:   Samples With DNA
Cytokine Multiplex, CRP, TRP, KYN, mRNA analysis, methylation analysis, and gene analysis


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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Female breast cancer patients who are chemotherapy treated and non chemotherapy-treated and medically healthy women without breast cancer in the control group
Criteria

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

Information from the National Library of Medicine

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


Locations
United States, Georgia
Emory University Department of Psychiatry and Behavioral Sciences
Atlanta, Georgia, United States, 30030
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Andrew H Miller, MD Emory University

Responsible Party: Andrew H Miller, Professor, Emory University
ClinicalTrials.gov Identifier: NCT02421978     History of Changes
Other Study ID Numbers: IRB00080062
First Posted: April 21, 2015    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018

Keywords provided by Andrew H Miller, Emory University:
Cognitive dysfunction
Inflammation
Fatigue
Decreased motivation

Additional relevant MeSH terms:
Breast Neoplasms
Inflammation
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pathologic Processes