Objective： 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-limitin...Objective： 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. Methods： 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 rain 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 forAdverse Events （NCI-CTCAE） version 3.0. Results： 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）. Conclusion： Use of IV Ca/Mg showed a statistically significant reduction of peripheral neuropathy （PN） in patients with CRC receiving oxaliplatin in the adjuvant settings.展开更多
文摘Objective： 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. Methods： 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 rain 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 forAdverse Events （NCI-CTCAE） version 3.0. Results： 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）. Conclusion： Use of IV Ca/Mg showed a statistically significant reduction of peripheral neuropathy （PN） in patients with CRC receiving oxaliplatin in the adjuvant settings.
