, Volume 14, Issue 11, pp 1134-1140
Date: 19 Apr 2006

A randomized controlled trial evaluating the efficacy and safety of vitamin E supplementation for protection against cisplatin-induced peripheral neuropathy: final results

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Abstract

Aim

A randomized, open label with blind assessment, controlled trial was performed to assess efficacy and adverse-event profile of vitamin E, given as supplementation for prophylaxis against cisplatin-induced peripheral neuropathy (CIPN).

Patients and methods

A total of 30 patients scheduled to receive six courses of cumulative cisplatin-based regimens were randomly allocated to treatment and control groups and were then studied by means of neurological examination and electrophysiological study. Patients assigned to group I (n=14) orally received vitamin E at a daily dose of 600 mg/day during chemotherapy and 3 months after its cessation were compared to patients of group II (n=16), who received no vitamin E supplementation and served as controls. The severity of neurotoxicity was summarized by means of a modified Peripheral Neuropathy (PNP) score.

Results

The incidence of neurotoxicity differed significantly between groups, occurring in 3/14 (21.4%) of patients assigned to the vitamin E supplementation group and in 11/16 (68.5%) of controls (p=0.026). The relative risk (RR) of developing neurotoxicity was significantly higher in case of controls, RR=2.51, 95% C.I.=1.16–5.47. Mean PNP scores were 4.99±1.33 for patients of group I and 10.47±10.62 for controls, (p=0.023). None of the adverse events or deaths occurred, were judged as likely to be related to the vitamin E supplementation.

Conclusion

Vitamin E effectively and safely protects patients with cancer from occurrence of cisplatin neurotoxicity.

Authors’ disclosure

: Part of the material reported herein has been previously published under the bibliographic reference, Argyriou AA et al., Neurology 2005; 64(1): 26–31.

Role of the funding source

: No funding source had a role in the preparation of this paper or in the decision to submit it for publication.