drugset / Trial / NCT02796755

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

NCT02796755

Phase 4 Completed 30 enrolled Emory University
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2016-04
Primary completion
2019-10-24
Completion
2019-10-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Riluzole Small molecule 100 mg Oral

Indications

No indication recorded.