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


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.


CONCLUSIONS
Vitamin E effectively and safely protects patients with cancer from occurrence of cisplatin neurotoxicity.
Argyriou
Andreas A
AA
EMG/ENG Laboratory, Department of Neurology, University of Patras Medical School, Rion-Patras, Greece.
Chroni
Elisabeth
E
Koutras
Angelos
A
Iconomou
Gregoris
G
Papapetropoulos
Spiridon
S
Polychronopoulos
Panagiotis
P
Kalofonos
Haralabos P
HP
D000200:Action Potentials / Q000187:drug effects; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects; D000975:Antioxidants / Q000009:adverse effects / Q000627:therapeutic use*; D018288:Carcinoma, Small Cell / Q000188:drug therapy; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects*; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy; D006801:Humans; D015994:Incidence; D008175:Lung Neoplasms / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced* / Q000503:physiopathology / Q000517:prevention & control*; D010543:Peroneal Nerve / Q000187:drug effects / Q000503:physiopathology; D011597:Psychomotor Performance / Q000187:drug effects; D012107:Research Design; D012720:Severity of Illness Index; D013274:Stomach Neoplasms / Q000188:drug therapy; D013736:Testicular Neoplasms / Q000188:drug therapy; D016896:Treatment Outcome; D014459:Ulnar Nerve / Q000187:drug effects / Q000503:physiopathology; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy; D014810:Vitamin E / Q000009:adverse effects / Q000627:therapeutic use*
D000970:Antineoplastic Agents; D000975:Antioxidants; D014810:Vitamin E; D002945:Cisplatin