Vitamin e neuroprotection for cisplatin neuropathy: A randomized, placebo-controlled trial

A. Pace, D. Giannarelli, E. Galiè, A. Savarese, S. Carpano, M. Della Giulia, A. Pozzi, A. Silvani, P. Gaviani, V. Scaioli, B. Jandolo, L. Bove, F. Cognetti

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Abstract

OBJECTIVE: The clinical use of cisplatin chemotherapy is limited by severe peripheral neurotoxicity reported in up to 90% of patients receiving a cumulative dose higher than 300 mg/m. The present study evaluates the neuroprotective effect of antioxidant supplementation (vitamin E) in patients treated with cisplatin chemotherapy. Methods: A total of 108 patients treated with cisplatin chemotherapy were randomly assigned to receive vitamin E supplementation (α-tocopherol 400 mg/day) or placebo. Treatment was started orally before chemotherapy and continued for 3 months after the suspension of cisplatin. Results: Of 108 randomized patients, 68 received at least one clinical and neurophysiologic examination after cisplatin CT; 41 patients received a cumulative dose of cisplatin higher than 300 mg/m and were eligible for statistical analysis: 17 in the vitamin E group (group 1) and 24 in the placebo group (group 2). The incidence of neurotoxicity was significantly lower in group 1 (5.9%) than in group 2 (41.7%) (p <0.01). The severity of neurotoxicity, measured with a validated neurotoxicity score (Total Neuropathy Score [TNS]), was significantly lower in patients receiving vitamin E than those receiving placebo (mean TNS 1.4 vs 4.1; p <0.01). Conclusions: This phase III study confirms the neuroprotective role of vitamin E against cisplatin peripheral neurotoxicity. Vitamin E supplementation should be adopted in patients receiving cisplatin-based chemotherapy. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that vitamin E supplementation significantly reduces the relative risk of developing signs or symptoms of neurotoxicity (relative risk = 0.14) (95% confidence interval = 0.02-1.00, p <0.05).

Original languageEnglish
Pages (from-to)762-766
Number of pages5
JournalNeurology
Volume74
Issue number9
DOIs
Publication statusPublished - Mar 2010

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ASJC Scopus subject areas

  • Clinical Neurology

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