Preventing paclitaxel-induced peripheral neuropathy: A phase II trial of vitamin E supplementation

A randomized, controlled trial was performed to assess the efficacy and safety of vitamin E supplementation for Prophylaxis against paclitaxel-induced peripheral neuropathy (PIPN). Thirty-two patients undergoing six courses of paclitaxel-based chemotherapy were randomly assigned to receive either chemotherapy with vitamin E (300 mg twice a day, Group I) or chemotherapy without vitamin E supplementation (Group II). A detailed neurological examination and electrophysiological study was performed during and 3 months after chemotherapy. The severity of PIPN was summarized by means of a modified Peripheral Neuropathy (PNP) score. The incidence of neurotoxicity differed significantly between groups, occurring in 3/16 (18.7 %) patients assigned to the vitamin E supplementation group and in 10/16 (62.5%) controls (P = 0.03). The relative risk (RR) of developing PIPN was significantly higher in controls than in vitamin E group patients (RR = 0.3, 95 % confidence interval (CI) = 0.1- 0.9). Mean PNP scores were 2.25 +/- 5.1 (range 0-15) for patients in Group I and 11 +/- 11.63 (range 0-32) for those in Group II (P = 0.01). Vitamin E supplementation was well tolerated and showed an excellent safely profile. This study shows that vitamin E effectively and safely Protects Patients with cancer from the occurrence of paclitaxel-induced peripheral nerve damage. A double-blind, placebo-controlled trial is needed to confirm these results.