Riluzole in Reducing Central Nervous System Glutamate and Fatigue in Stage I-III Breast Cancer Survivors with High Inflammation

Inclusion Criteria

• Patients with stage I-III breast cancer
• Patients that are between 1-5 years post treatment
• Participants will have completed surgery (lumpectomy or mastectomy) with or without neoadjuvant or adjuvant chemotherapy and with or without radiation
• Subjects must have a C-reactive protein (CRP) > 3 mg/L
• Subjects must have a Single Item Screening Scale for Fatigue score of >= 4 (out of 10 points, 0 being no fatigue and 10 being severe, incapacitating fatigue) to be eligible for the trial

Exclusion Criteria

• No patients will be enrolled from vulnerable populations, including neonates, children, prisoners, or institutionalized individuals
• No use will be made of fetal tissue
• Potential subjects will be excluded for a number of medical conditions that might represent a risk for riluzole (including history of allergic reaction to riluzole and evidence of liver disease) and potentially confound the relationship among CNS glutamate, inflammation and behavior/cognition, including: autoimmune or inflammatory disorders, chronic infectious diseases (e.g. human immunodeficiency virus [HIV], hepatitis B or C), pregnancy, neurologic disorders (including a history of serious head trauma or seizures), liver disease (as manifested as an elevation in liver transaminases), uncontrolled cardiovascular, metabolic, pulmonary or renal disease (as determined by medical history and laboratory testing)
• Subjects with a current or past history of schizophrenia will also be excluded
• Subjects with bipolar disorder that have experienced a manic episode within 6 months of study entry will be excluded or at the principal investigator (PI)’s discretion
• Subjects receiving antidepressants, mood stabilizers, antipsychotic medications or benzodiazepines or drugs known to affect the immune system (e.g. glucocorticoids, methotrexate) will also be excluded unless otherwise approved by the PI discretion
• Subjects who exhibit signs of an infection at screening will be rescheduled when symptoms have resolved
• Subjects who exhibit signs of infection or a significant change from baseline test measurements via safety labs will be informed