Effects of Riluzole on CNS Glutamate and Fatigue in Breast Cancer Survivors With High Inflammation
Condition: Inflammation; Fatigue
MeSH terms: Inflammation; Fatigue
Intervention: Riluzole; Placebo
Intervention description: Study participants randomized to this arm will take 100 mg/day of riluzole for 8 weeks.; Study participants randomized to this arm will take a placebo, that matches the appearance of 100 mg tablets of riluzole, daily for 8 weeks.
Intervention MeSH terms: Riluzole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: Female
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Central Nervous System (CNS) Glutamate; Breast Cancer Treatment; Fatigue; Cognitive Dysfunction; Behavioral; Psychometrics; Imaging Technology; Magnetic Resonance Spectroscopy

Summary:

      The goal of the proposed research is to determine whether riluzole, a drug that increases
      glutamate reuptake, will decrease central nervous system (CNS) glutamate in breast cancer
      survivors with increased inflammation and fatigue. The researchers will also determine
      whether decreasing glutamate with riluzole will reverse inflammation-related fatigue and
      other symptoms including cognitive dysfunction and decreased motivation. To accomplish these
      goals, the researchers plan to conduct an 8 week, double-blind, randomized control trial of
      riluzole (100 mg/d) versus placebo in 40 breast cancer survivors (n=20 per group). All breast
      cancer survivors will have completed treatment within 1-3 years and have a fatigue level of
      ≥4 (on a 10 point scale) and a plasma c-reactive protein (CRP) concentration >3mg/L
      (indicative of high inflammation). Participants will undergo magnetic resonance spectroscopy
      (MRS) to measure CNS glutamate before and after 2 and 8 weeks of riluzole or placebo
      treatment. Fatigue and other behavioral assessments including measures of cognitive function
      and motivation will be conducted before and after treatment and correlated with the change in
      CNS glutamate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have completed surgery for Stage I-III breast cancer (lumpectomy or mastectomy)
             with or without neoadjuvant or adjuvant chemotherapy and with or without radiation.

          -  Must be 1-5 years post-treatment for breast cancer

          -  Must have a plasma c-reactive protein (CRP) level of >3mg/L

          -  Must have a score of ≥4 (out of 10 points, 0 being no fatigue and 10 being severe,
             incapacitating fatigue) on a Single Item Screening Scale for Fatigue

        Exclusion Criteria:

          -  Presence of a medical condition that might represent a risk for riluzole treatment,
             including history of allergic reaction to riluzole and evidence of liver disease

          -  Presence of a medical condition that might potentially confound the relationship among
             CNS glutamate, inflammation and behavior/cognition, including autoimmune or
             inflammatory disorders, chronic infectious diseases (e.g. 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) and
             uncontrolled cardiovascular, metabolic, pulmonary or renal disease (as determined by
             medical history and laboratory testing)

          -  Current or past history of schizophrenia

          -  Individuals with bipolar disorder who have experienced a manic episode within 6 months
             of study entry, or at the discretion of the study doctor

          -  Individuals receiving antidepressants, mood stabilizers, antipsychotic medications or
             benzodiazepines or drugs known to affect the immune system (e.g. glucocorticoids,
             methotrexate), or at the discretion of the study doctor

          -  Individuals exhibiting signs of infection at the screening visit will be rescheduled
             to screen when symptoms have resolved