Preventing paclitaxel-induced peripheral neuropathy: a phase II trial of vitamin E supplementation

J Pain Symptom Manage. 2006 Sep;32(3):237-44. doi: 10.1016/j.jpainsymman.2006.03.013.


A randomized, controlled trial was performed to assess the efficacy and safety of vitamin E supplementation for prophylaxis against paclitaxel-induced peripheral neuropathy (PIPN). Thirty-two patients undergoing six courses of paclitaxel-based chemotherapy were randomly assigned to receive either chemotherapy with vitamin E (300 mg twice a day, Group I) or chemotherapy without vitamin E supplementation (Group II). A detailed neurological examination and electrophysiological study was performed during and 3 months after chemotherapy. The severity of PIPN was summarized by means of a modified Peripheral Neuropathy (PNP) score. The incidence of neurotoxicity differed significantly between groups, occurring in 3/16 (18.7%) patients assigned to the vitamin E supplementation group and in 10/16 (62.5%) controls (P=0.03). The relative risk (RR) of developing PIPN was significantly higher in controls than in vitamin E group patients (RR=0.3, 95% confidence interval (CI)=0.1-0.9). Mean PNP scores were 2.25+/-5.1 (range 0-15) for patients in Group I and 11+/-11.63 (range 0-32) for those in Group II (P=0.01). Vitamin E supplementation was well tolerated and showed an excellent safety profile. This study shows that vitamin E effectively and safely protects patients with cancer from the occurrence of paclitaxel-induced peripheral nerve damage. A double-blind, placebo-controlled trial is needed to confirm these results.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / therapeutic use
  • Dietary Supplements*
  • Drug Combinations
  • Female
  • Humans
  • Male
  • Middle Aged
  • Neoplasms / complications*
  • Neoplasms / drug therapy
  • Paclitaxel / adverse effects*
  • Paclitaxel / therapeutic use
  • Peripheral Nervous System Diseases / chemically induced*
  • Peripheral Nervous System Diseases / prevention & control*
  • Treatment Outcome
  • Vitamin E / administration & dosage*


  • Antineoplastic Agents
  • Drug Combinations
  • Vitamin E
  • Paclitaxel