A randomized controlled trial evaluating the efficacy and safety of vitamin E su

April 20, 2006

Support Care Cancer. 2006 Apr 19

A randomized controlled trial evaluating the efficacy and safety of

vitamin E supplementation for protection against cisplatin-induced

peripheral neuropathy: final results.

Argyriou AA, Chroni E, Koutras A, Iconomou G, Papapetropoulos S,

Polychronopoulos P, Kalofonos HP.

EMG/ENG Laboratory, Department of Neurology, University of Patras

Medical School, Rion-Patras, Greece.

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.

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