Phase 4
Completed N=30
Effects of Riluzole on CNS Glutamate and Fatigue in Breast Cancer Survivors With High Inflammation
Source: ClinicalTrials.gov NCT02796755 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcomePrimary: Central Nervous System (CNS) Glutamate Measured by Magnetic Resonance Spectroscopy (MRS) — 1.26; 1.2; 1.26; 1.27 Glu/Cr
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Central Nervous System (CNS) Glutamate Measured by Magnetic Resonance Spectroscopy (MRS) |
1.26; 1.2; 1.26; 1.27; 1.27; 1.27 | — |
| SECONDARY Multidimensional Fatigue Inventory (MFI) Score |
66.90; 58.90; 63.80; 53.50; 62.00; 53.21 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue Short Form Score |
25.1; 21.8; 22.5; 18.71; 23.7; 17.07 | — |
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
Data sourced from ClinicalTrials.gov (NCT02796755). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.