Effects of Riluzole on CNS Glutamate and Fatigue in Breast Cancer Survivors With High Inflammation

• Register: ClinicalTrials.gov
• Last refreshed on: 25 January 2021
• Main ID: NCT02796755
• Date of registration: 02/06/2016
• Prospective Registration: No
• Primary sponsor: Emory University
• Public title: Effects of Riluzole on CNS Glutamate and Fatigue in Breast Cancer Survivors With High Inflammation
• Scientific title: Effects of Riluzole on CNS Glutamate and Fatigue in Breast Cancer Survivors With High Inflammation
• Date of first enrolment: April 2016
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02796755
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Andrew H Miller, MD
• Affiliation: Emory University

Key inclusion & exclusion 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



Age minimum: 21 Years
Age maximum: 65 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Fatigue

Inflammation

Intervention(s)

Drug: Placebo

Drug: Riluzole

Primary Outcome(s)

Change in Central Nervous System (CNS) glutamate measured by Magnetic Resonance Spectroscopy (MRS) between riluzole and placebo arms [Time Frame: Baseline 1 visit and at 1 and 8 weeks of treatment (8 weeks)]

Secondary Outcome(s)

Change in score of the Multidimensional Fatigue Inventory (MFI) between riluzole and placebo arms [Time Frame: Baseline 1 visit through end of treatment (up to 8 weeks)]

Change in score of the Promise-Fatigue Short Form (PROMIS) [Time Frame: Baseline 1 visit through end of treatment (up to 8 weeks)]

Secondary ID(s)

IRB00086271

Source(s) of Monetary Support

Please refer to primary and secondary sponsors