Evaluating the effects of duloxetine on prophylaxis of oxaliplatin-induced peripheral neuropathy in patients with gastrointestinal cancer: A randomized double-blind placebo controlled clinical trial.

Forty patients were randomly assigned to treatment and placebo groups which were similar to each other in terms of chemotherapy regimen, type, and stage of cancer. Analysis of results obtained from the NCI-CTCAE (v4.03) showed that duloxetine could prevent worsening of paresthesia more than placebo (P = 0.025) and patients in duloxetine group experienced less peripheral sensory neuropathy (P = 0.001) than placebo group. Analysis of results obtained from the FACT/GOG-NTX demonstrated a significant worsening of tingling and discomfort in hands (P = 0.002, 0.001, respectively) and feet (P = 0.017, 0.019, respectively) in placebo group compared to duloxetine group. Also, patients experienced more cold temperature -induced pain in extremities (P = 0.001) in placebo group compared to duloxetine group. On the other hand, duloxetine could not improve QOL (P = 0.06) and had not significant effects on trouble feeling the shape of small objects in hand (P = 0.420) or trouble buttoning buttons (P = 0.086). The P-value < 0.05 was considered to be statistically significant.