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 safety 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.
Argyriou
Andreas A
AA
EMG Laboratory, Department of Neurology, University of Patras Medical School, Rion-Patras, Greece. andargyriou@yahoo.gr
Chroni
Elisabeth
E
Koutras
Angelos
A
Iconomou
Gregoris
G
Papapetropoulos
Spiridon
S
Polychronopoulos
Panagiotis
P
Kalofonos
Haralabos P
HP
D000284:Administration, Oral; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D019587:Dietary Supplements; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications* / Q000188:drug therapy; D017239:Paclitaxel / Q000009:adverse effects* / Q000627:therapeutic use; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced* / Q000517:prevention & control*; D016896:Treatment Outcome; D014810:Vitamin E / Q000008:administration & dosage*
D000970:Antineoplastic Agents; D004338:Drug Combinations; D014810:Vitamin E; D017239:Paclitaxel