A phase III, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of pregabalin in the prevention and reduction of oxaliplatin-induced painful neuropathy (PreOx).

3575 Background: Patients with colorrectal cancer receiving Oxaliplatin usually develop acute and chronic painful chemotherapy-induced peripheral neuropathy (CIPN). Despite having different mechanisms, both conditions lead to central sensitization (CS). Recent data suggest that the degree of CS after acute use of Oxaliplatin increases the risk of painful CIPN. We hypothesized that preemptive use of anti-hyperalgesic drug (pregabaline) during Oxaliplatin infusions would decrease the incidence of chronic painful CIPN. Methods: Pain-free, chemotherapy-naive patients (stage III/IV) receiving at least one complete cycle of modified FLOX (5-FU+leucovorin for 6 consecutive weeks+oxaliplatin 85 mg/m2 at weeks 1, 3 and 5, every 8 weeks) were randomised (1:1). Eligible patients received either pregabaline or placebo (150-600mg/d) for three days before and three days after each oxaliplatin infusion. Patients were followed for 3-6 months after the end of chemotherapy. Clinical assessments were performed at baseline, ...