Does Riluzole reduce the incidence of chemotherapy-induced nerve injury in patients with colorectal cancer?
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ABSTRACT: Interventions: Patients receiving oxaliplatin chemotherapy for colorectal cancer will be randomised into either the study drug arm or placebo control arm. Participants will be started on either riluzole 50 mg oral tablet twice daily or the twice daily lactose placebo tablet. Following randomisation, therapy will be continued for the duration of oxaliplatin treatment (4-6 months) and for 2 weeks following treatment cessation.
Primary outcome(s): To assess whether treatment with riluzole results in a reduction in the development of chronic neuropathy and neuropathic symptoms
The severity of neuropathy will be assessed using the Total Neuropathy Score (TNS). This will be used to evaluate neuropathy in a number of different categories; sensory neuropathic symptoms, examination findings and nerve conduction results.[Assessed at 6 monthly intervals following randomisation for 2 years]
Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy
DISEASE(S): Neurological-other Neurological Disorders,Colorectal Cancer,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Oxaliplatin-induced Neurotoxicity
PROVIDER: 2456970 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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