Ibudilast for the prevention of nerve symptoms caused by oxalipatin chemotherapy, in patients with metastatic gastrointestinal cancer

Interventions: Ibudilast is a non-selective phosphodiesterase (PDE) inhibitor with anti-inflammatory properties which has shown to improve acute neurotoxicity in animal models. The study intervention will be oral ibudilast 30mg twice daily for the duration of one cycle, named Cycle B. The duration of the cycle is 2 weeks for patients receiving infusional fluorouracil with oxaliplatin (FOLFOX) and 3 weeks for patients receiving oral capecitabine with oxaliplatin (CapeOx). There is no washout period. Drug tablet return at the end of the cycle and weekly phone contact will be used to monitor adherence to the intervention.
Primary outcome(s): Proportion of patients developing neurotoxicity > Grade 2 following their chemotherapy cycle as measured by the oxaliplatin-specific neurotoxicity scale (OSNS) modified. Compared between day 3 of cycle A vs Day 3 of cycle B.[Day 3 of chemotherapy cycles]
Study Design: Purpose: Prevention; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Crossover;Type of endpoint: Safety/efficacy