Pace, A., Savarese, A., Picardo, M., Maresca, V., Pacetti, U., Del Monte, G., . . . Bove, L. (2003). Neuroprotective effect of vitamin E supplementation in patients treated with cisplatin chemotherapy. Journal of Clinical Oncology, 21, 927–931.

DOI Link

Study Purpose

This study evaluated the neuroprotective effect of vitamin E in patients with solid tumor malignancy treated with cisplatin chemotherapy.

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to either group 1, which received vitamin E supplementation during cisplatin chemotherapy, or to group 2, which received cisplatin chemotherapy alone. Vitamin E 300 mg per day was administered orally before cisplatin chemotherapy and continued for three months after the suspension of treatment.

Sample Characteristics

  • A total sample of 47 patients was recruited. Twenty-seven completed the study.
  • Patients had a variety of solid organ malignancies.
  • Exclusion criteria included previous chemotherapy treatment or regimens including other neurotoxic drugs.

Measurement Instruments/Methods

  • Assessment of neuropathic symptoms, pinprick, vibratory sensations, strength, and deep tendon reflexes.
  • A follow-up neurologic examination was performed by the same neurologists (not blinded to treatment status) after the three cycles of cisplatin treatment and after the cessation of chemotherapy. Neuropathic signs and symptoms were scored using a questionnaire designed for the detection of sensory disturbances (e.g., paresthesia, pain, and burning in feet or fingers) experienced by patients.
  • Nerve conduction velocity and the amplitude of potentials of the sensory median and sural nerves were assessed at baseline and at the end of treatment with vitamin E.
  • Plasma levels of vitamin E were measured by gas chromatography-mass spectrometry prior to chemotherapy.

Results

Twenty patients dropped out of the study. Plasma levels of vitamin E were in the normal range and not significantly different between the two groups (8.06 and 7.17 mg/ml, respectively). Twelve of the 14 patients in the control group developed CIPN as compared to 4 of 13 patients who received vitamin E supplementation.

 

Conclusions

Vitamin E supplementation significantly protects against cisplatin-induced peripheral neuropathy and reduces incidence and intensity of neurologic signs and symptoms.

Limitations

  • The small sample size and differing tumor types included make comparisons difficult.
  • The small sample size can also make finding statistically significant results more likely by chance alone.