Pace, A., Giannarelli, D., Galie, E., Savarese, A., Carpano, S., Della Giulia, M., . . . Cognetti, F. (2010). Vitamin E neuroprotection for cisplatin neuropathy: a randomized, placebo-controlled trial. Neurology, 74, 762–766.

 

The aim of the study was to evaluate the neuroprotective effect of vitamin E in patients treated with cisplatin.

Patients were randomized to either vitamin E 400 mg per day (α-tocopherol) or placebo. The vitamin E (or placebo) was started orally before chemotherapy and continued for three months after completion of cisplatin.

• The study had a total sample of 108 patients. Forty-one were included in the analysis.
• Mean age was 58 years, with a range of 28–74 years.
• Patients had solid tumors and were in generally good health and receiving cisplatin therapy.

The study was conducted at multiple outpatient sites: the National Cancer Institute in Rome and the National Neurologic Institute in Milan, Italy.

The study had a phase III randomized, placebo-controlled trial design.

• Neurologic examination: Standardized history and assessment of pinprick and vibratory sensations, strength, and deep tendon reflexes.              
• Total neuropathy score
• Reidel-Seiffer tuning fork
• Electrophysiologic examination

Neurotoxicity score was significantly lower in patients receiving vitamin E than in the placebo group (mean score of 1.4 versus 4.1; unpaired t test, p < 0.01). Neurotoxicity incidence differed significantly between groups (group 1, 1 of 17 participants; group 2, 10 of 24 participants; p < 0.01). Also, the relative risk of developing signs or symptoms of neurotoxicity was significantly lower in group 1 than group 2 (relative risk of 0.14, 95% confidence interval [0.02, 1],  p < 0.05). At follow-up, compared with baseline, mean sural and sensory median nerve amplitude values were significantly decreased in the control group (p = 0.02 and p = 0.008, respectively), while median nerve amplitude was unchanged and sural nerve amplitude was decreased, but not significantly, in patients receiving Vitamin E.

Vitamin E may be helpful in reducing neurotoxic effects of cisplatin, but larger randomized trials are needed.

• The study was limited by a small sample size (less than 100).
• In addition, a large number of dropouts were reported.

Cisplatin-induced peripheral neuropathy can be painful and also interfere with a patient’s quality of life; however, future research is needed with larger trials before Vitamin E is recommended. Also, drug interactions need to be considered.