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The use of vitamin E for the prevention of chemotherapy-induced peripheral neuropathy: results of a randomized phase III clinical trial

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Abstract

Background

Chemotherapy-induced peripheral neuropathy (CIPN) continues to be a substantial problem for many cancer patients. Pursuant to promising appearing pilot data, the current study evaluated the use of vitamin E for the prevention of CIPN.

Methods

A phase III, randomized, double-blind, placebo-controlled study was conducted in patients undergoing therapy with neurotoxic chemotherapy, utilizing twice daily dosing of vitamin E (400 mg)/placebo. The primary endpoint was the incidence of grade 2+ sensory neuropathy (SN) toxicity (CTCAE v 3.0) in each treatment arm, analyzed by chi-square testing. Planned sample size was 100 patients per arm to provide 80% power to detect a difference in incidence of grade 2+ SN toxicity from 25% in the placebo group to 10% in the vitamin E group.

Results

Two-hundred seven patients were enrolled between December 1, 2006 and December 14, 2007, producing 189 evaluable cases for analysis. Cytotoxic agents included taxanes (109), cisplatin (8), carboplatin (2), oxaliplatin (50), or combination (20). There was no difference in the incidence of grade 2+ SN between the two arms (34%—vitamin E, 29%—placebo; P = 0.43). There were no significant differences between treatment arms for time to onset of neuropathy (P = 0.58), for chemotherapy dose reductions due to neuropathy (P = 0.21), or for secondary endpoints derived from patient-reported neuropathy symptom assessments. The treatment was well tolerated overall.

Conclusions

Vitamin E did not appear to reduce the incidence of sensory neuropathy in the studied group of patients receiving neurotoxic chemotherapy.

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Acknowledgments

This study was conducted as a collaborative trial of the North Central Cancer Treatment Group and Mayo Clinic and was supported in part by Public Health Service grants CA-25224, CA-37404, CA-35113, and 124477.

Conflict of interest

None.

Author information

Authors and Affiliations

  1. Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA

    Lisa A. Kottschade, Jeff A. Sloan, DeAnne A. Smith & Charles L. Loprinzi

  2. Siouxland Hematology-Oncology Associates, Sioux City, SD, 57105, USA

    Miroslaw A. Mazurczak

  3. Wichita Community Clinical Oncology, Wichita, KS, 67214-3882, USA

    David B. Johnson

  4. Metro-Minnesota Community Clinical Oncology Program, St. Louis Park, MN, 55416, USA

    Bronagh P. Murphy

  5. Carle Cancer Center CCOP, Urbana, IL, 61801, USA

    Kendrith M. Rowland

  6. Missouri Valley Cancer Consortium, Omaha, NE, 68106, USA

    Alan R. Berg

  7. Michigan Cancer Research Consortium, Ann Arbor, MI, 48106, USA

    Philip J. Stella

Authors
  1. Lisa A. Kottschade
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  2. Jeff A. Sloan
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  3. Miroslaw A. Mazurczak
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  4. David B. Johnson
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  7. DeAnne A. Smith
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  8. Alan R. Berg
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  10. Charles L. Loprinzi
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Corresponding author

Correspondence to Lisa A. Kottschade.

Appendices

Appendix I

Table 4 Neurotoxicity evaluation
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Appendix II—Symptom experience diary

figure a

Appendix III—Neuropathy specific question

figure b

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Kottschade, L.A., Sloan, J.A., Mazurczak, M.A. et al. The use of vitamin E for the prevention of chemotherapy-induced peripheral neuropathy: results of a randomized phase III clinical trial. Support Care Cancer 19, 1769–1777 (2011). https://doi.org/10.1007/s00520-010-1018-3

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  • DOI: https://doi.org/10.1007/s00520-010-1018-3

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