RiluzolE FOr Preventing Cognitive DysfUnction in Cancer PatientS Receiving Chemotherapy (REFOCUS)
Summary
This is a phase II single-arm, Phase 2a, randomized, double-blinded, placebo-controlled pilot clinical trial determining efficacy of riluzole in preventing cognitive dysfunction in subjects with cancer, who are receiving chemotherapy.
Arms & interventions
- DrugRiluzole
Given PO
- OtherPlacebo
Given PO
Outcome measures
Primary
Change in circulating Brain-Derived Neurotrophic Factor (BDNF) levels over time in cancer patients receiving chemotherapy
Comparing mean plasma BDNF values at each patient visit point, including before the intervention, at subsequent ongoing safety monitoring visits, and at the endpoint of the study.
Time frame: 6 months
Secondary
Cognitive Function Scores (FACT-Cog)
Time frame: 6 months
Cognitive Function Scores (CANTAB)
Time frame: 6 months
Eligibility criteria
Study locations (1)
Chao Family Comprehensive Cancer Center, University of California Irvine
Orange, California, 92868