Role of calcium and magnesium infusion in prevention of oxaliplatin neurotoxicity. A phase III trial

Abstract

This study is a prospective randomized, double-blind, placebo-controlled study to evaluate the effect of calcium and magnesium (Ca/Mg) infusion on amelioration of oxaliplatin neuropathy, the dose-limiting toxicity. Sixty patients with resected colorectal carcinoma (CRC) planned to receive adjuvant oxaliplatin-containing regimen were randomly assigned to two arms; Arm A: patients received Ca/Mg were given as 1 gm Ca gluconate and 1 gm MgSO4 in 250 mL of intravenous (IV) solution over 30 min pre and post oxaliplatin infusion, and Arm B: patients received 250 mL of IV solution without Ca/Mg over 30 min pre and post oxaliplatin infusion. Primary outcome was to assess percentage of patients with oxaliplatin-induced neurotoxicity. Neurotoxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0. Sixty patients in both arms were assessed, 30 with Ca/Mg infusion and 30 without. Patients developed neurotoxicity in arm A were significantly lower than that in arm B after the end of treatment; 7 (23.3%) and 14 (46.6%) respectively (P < 0.05), and significantly lower duration of neuropathy in months (8 ± 2.5 vs 18 ± 3) respectively (P < 0.001). Use of IV Ca/Mg showed a statistically significant reduction of peripheral neuropathy (PN) in patients with CRC receiving oxaliplatin in the adjuvant settings.