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

Support Care Cancer. 2006 Nov;14(11):1134-40. doi: 10.1007/s00520-006-0072-3. Epub 2006 Apr 19.


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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Action Potentials / drug effects
  • Adult
  • Aged
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / adverse effects*
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antioxidants / adverse effects
  • Antioxidants / therapeutic use*
  • Carcinoma, Small Cell / drug therapy
  • Cisplatin / administration & dosage
  • Cisplatin / adverse effects*
  • Dietary Supplements*
  • Double-Blind Method
  • Female
  • Head and Neck Neoplasms / drug therapy
  • Humans
  • Incidence
  • Lung Neoplasms / drug therapy
  • Male
  • Middle Aged
  • Peripheral Nervous System Diseases / chemically induced*
  • Peripheral Nervous System Diseases / physiopathology
  • Peripheral Nervous System Diseases / prevention & control*
  • Peroneal Nerve / drug effects
  • Peroneal Nerve / physiopathology
  • Psychomotor Performance / drug effects
  • Research Design
  • Severity of Illness Index
  • Stomach Neoplasms / drug therapy
  • Testicular Neoplasms / drug therapy
  • Treatment Outcome
  • Ulnar Nerve / drug effects
  • Ulnar Nerve / physiopathology
  • Uterine Cervical Neoplasms / drug therapy
  • Vitamin E / adverse effects
  • Vitamin E / therapeutic use*


  • Antineoplastic Agents
  • Antioxidants
  • Vitamin E
  • Cisplatin