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document
The use of vitamin E for the prevention of chemotherapy-induced peripheral neuropathy : results of a randomized phase III clinical trial . 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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Intervention_Pharmacological
vitamin E
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Intervention_Pharmacological
vitamin E
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Intervention_Pharmacological
twice daily dosing of vitamin E ( 400 mg )
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Intervention_Control
/placebo
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Intervention_Pharmacological
-vitamin E
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Outcome_Adverse-effects
incidence of grade 2+ sensory neuropathy ( SN ) toxicity ( CTCAE v 3.0 )
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Outcome_Adverse-effects
grade 2+ SN toxicity
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Outcome_Physical
grade 2+ SN
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Participant_Condition
cancer
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Participant_Sample-size
100
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Participant_Sample-size
Two-hundred seven
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Participant_Sample-size
189