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Inflammation-Induced CNS Glutamate During Breast Cancer Treatment

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Emory University

Status

Completed

Conditions

Breast Cancer

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT02421978
1R21MH105897 (U.S. NIH Grant/Contract)
IRB00080062

Details and patient eligibility

About

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.

Full 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.

Enrollment

98 patients

Sex

Female

Ages

21 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

98 participants in 3 patient groups

Chemotherapy-treated breast cancer group
Description:
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
Description:
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
Description:
Age and race-matched healthy women will complete the neuropsychiatric assessment battery, blood sampling, self-report forms and magnetic resonance spectroscopy (MRS) scans

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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