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, De Anne A.
AU - Berg, Alan R.
AU - Stella, Philip J.
AU - Loprinzi, Charles L.
N1 - Funding Information:
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.
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
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U2 - 10.1007/s00520-010-1018-3
DO - 10.1007/s00520-010-1018-3
M3 - Article
C2 - 20936417
AN - SCOPUS:83255166592
SN - 0941-4355
VL - 19
SP - 1769
EP - 1777
JO - Supportive Care in Cancer
JF - Supportive Care in Cancer
IS - 11
ER -