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

Lisa A. Kottschade, Jeff A Sloan, Miroslaw A. Mazurczak, David B. Johnson, Bronagh P. Murphy, Kendrith M. Rowland, DeAnne A. Smith, Alan R. Berg, Philip J. Stella, Charles Lawrence Loprinzi

Research output: Contribution to journalArticle

93 Citations (Scopus)

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, placebocontrolled 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.

Original languageEnglish (US)
Pages (from-to)1769-1777
Number of pages9
JournalSupportive Care in Cancer
Volume19
Issue number11
DOIs
StatePublished - Nov 2011

Fingerprint

Phase III Clinical Trials
Peripheral Nervous System Diseases
Vitamin E
Randomized Controlled Trials
Drug Therapy
oxaliplatin
Incidence
Placebos
Taxoids
Symptom Assessment
Carboplatin
Cytotoxins
Therapeutics
Double-Blind Method
Sample Size
Cisplatin
Neoplasms

Keywords

  • Chemotherapy-induced peripheral neuropathy
  • Sensory neuropathy toxicity
  • Vitamin E

ASJC Scopus subject areas

  • Oncology

Cite this

The use of vitamin E for the prevention of chemotherapy-induced peripheral neuropathy : Results of a randomized phase III clinical trial. / Kottschade, Lisa A.; Sloan, Jeff A; Mazurczak, Miroslaw A.; Johnson, David B.; Murphy, Bronagh P.; Rowland, Kendrith M.; Smith, DeAnne A.; Berg, Alan R.; Stella, Philip J.; Loprinzi, Charles Lawrence.

In: Supportive Care in Cancer, Vol. 19, No. 11, 11.2011, p. 1769-1777.

Research output: Contribution to journalArticle

Kottschade, Lisa A. ; Sloan, Jeff A ; Mazurczak, Miroslaw A. ; Johnson, David B. ; Murphy, Bronagh P. ; Rowland, Kendrith M. ; Smith, DeAnne A. ; Berg, Alan R. ; Stella, Philip J. ; Loprinzi, Charles Lawrence. / The use of vitamin E for the prevention of chemotherapy-induced peripheral neuropathy : Results of a randomized phase III clinical trial. In: Supportive Care in Cancer. 2011 ; Vol. 19, No. 11. pp. 1769-1777.
@article{dcb0c112ca064b19bf5971794b8fdab0,
title = "The use of vitamin E for the prevention of chemotherapy-induced peripheral neuropathy: Results of a randomized phase III clinical trial",
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, placebocontrolled 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.",
keywords = "Chemotherapy-induced peripheral neuropathy, Sensory neuropathy toxicity, Vitamin E",
author = "Kottschade, {Lisa A.} and Sloan, {Jeff A} and Mazurczak, {Miroslaw A.} and Johnson, {David B.} and Murphy, {Bronagh P.} and Rowland, {Kendrith M.} and Smith, {DeAnne A.} and Berg, {Alan R.} and Stella, {Philip J.} and Loprinzi, {Charles Lawrence}",
year = "2011",
month = "11",
doi = "10.1007/s00520-010-1018-3",
language = "English (US)",
volume = "19",
pages = "1769--1777",
journal = "Supportive Care in Cancer",
issn = "0941-4355",
publisher = "Springer Verlag",
number = "11",

}

TY - JOUR

T1 - The use of vitamin E for the prevention of chemotherapy-induced peripheral neuropathy

T2 - Results of a randomized phase III clinical trial

AU - Kottschade, Lisa A.

AU - Sloan, Jeff A

AU - Mazurczak, Miroslaw A.

AU - Johnson, David B.

AU - Murphy, Bronagh P.

AU - Rowland, Kendrith M.

AU - Smith, DeAnne A.

AU - Berg, Alan R.

AU - Stella, Philip J.

AU - Loprinzi, Charles Lawrence

PY - 2011/11

Y1 - 2011/11

N2 - 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, placebocontrolled 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.

AB - 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, placebocontrolled 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.

KW - Chemotherapy-induced peripheral neuropathy

KW - Sensory neuropathy toxicity

KW - Vitamin E

UR - http://www.scopus.com/inward/record.url?scp=83255166592&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=83255166592&partnerID=8YFLogxK

U2 - 10.1007/s00520-010-1018-3

DO - 10.1007/s00520-010-1018-3

M3 - Article

C2 - 20936417

AN - SCOPUS:83255166592

VL - 19

SP - 1769

EP - 1777

JO - Supportive Care in Cancer

JF - Supportive Care in Cancer

SN - 0941-4355

IS - 11

ER -