This phase II trial tests how well riluzole works in improving circulating brain-derived neurotrophic factor (BDNF) levels in cancer survivors with cancer related cognitive impairment (CRCI). CRCI encompasses a wide range of symptoms during and after treatment such as memory loss, inability to concentrate, difficulty in thinking, poor response speed and executive functioning. BDNF is a common protein prevalent in blood plasma having proven associations with cognitive impairments. Riluzole is approved for the treatment of a nerve disease called amyotrophic lateral sclerosis. However, its impact on BDNF levels and cognitive function have yet to be explored in cancer patients and survivors. Riluzole may work to improve BDNF levels in cancer survivors with CRCI.
Additional locations may be listed on ClinicalTrials.gov for NCT06580002.
Locations matching your search criteria
United States
California
Orange
UC Irvine Health/Chao Family Comprehensive Cancer CenterStatus: Active
Contact: Alexandre Chan
Phone: 949-824-8896
PRIMARY OBJECTIVES:
I. To evaluate the impact of riluzole against placebo control on circulating BDNF levels over time in cancer survivors experiencing CRCI.
II. To assess the clinical benefit of riluzole in CRCI management in cancer survivors experiencing CRCI.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive riluzole orally (PO) twice daily (BID) for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection on study and may undergo magnetic resonance imaging (MRI) on study.
ARM II: Patients receive placebo PO BID for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection on study and may undergo MRI on study.
After completion of study treatment, patients are followed up at 30 days.
Lead OrganizationUC Irvine Health/Chao Family Comprehensive Cancer Center
Principal InvestigatorAlexandre Chan