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document
Preventing paclitaxel-induced peripheral neuropathy : a phase II trial of vitamin E supplementation . A randomized , controlled trial was performed to assess the efficacy and safety of vitamin E supplementation for prophylaxis against paclitaxel-induced peripheral neuropathy ( PIPN ) . Thirty-two patients undergoing six courses of paclitaxel-based chemotherapy were randomly assigned to receive either chemotherapy with vitamin E ( 300 mg twice a day , Group I ) or chemotherapy without vitamin E supplementation ( Group II ) . A detailed neurological examination and electrophysiological study was performed during and 3 months after chemotherapy . The severity of PIPN was summarized by means of a modified Peripheral Neuropathy ( PNP ) score . The incidence of neurotoxicity differed significantly between groups , occurring in 3/16 ( 18.7 % ) patients assigned to the vitamin E supplementation group and in 10/16 ( 62.5 % ) controls ( P=0.03 ) . The relative risk ( RR ) of developing PIPN was significantly higher in controls than in vitamin E group patients ( RR=0.3 , 95 % confidence interval ( CI ) =0.1-0.9 ) . Mean PNP scores were 2.25+/-5.1 ( range 0-15 ) for patients in Group I and 11+/-11.63 ( range 0-32 ) for those in Group II ( P=0.01 ) . Vitamin E supplementation was well tolerated and showed an excellent safety profile . This study shows that vitamin E effectively and safely protects patients with cancer from the occurrence of paclitaxel-induced peripheral nerve damage . A double-blind , placebo-controlled trial is needed to confirm these results .
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Intervention_Pharmacological
vitamin E supplementation
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Intervention_Pharmacological
vitamin E supplementation
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Intervention_Pharmacological
paclitaxel-based chemotherapy
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Intervention_Pharmacological
chemotherapy with vitamin E
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Intervention_Pharmacological
chemotherapy without vitamin E supplementation
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Intervention_Pharmacological
chemotherapy
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Intervention_Pharmacological
vitamin E supplementation
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Intervention_Pharmacological
vitamin E
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Intervention_Pharmacological
Vitamin E supplementation
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Intervention_Pharmacological
vitamin E
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Intervention_Control
placebo-controlled
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Outcome_Physical
paclitaxel-induced peripheral neuropathy
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Outcome_Other
efficacy and safety
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Outcome_Physical
paclitaxel-induced peripheral neuropathy ( PIPN )
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Outcome_Other
detailed neurological examination and electrophysiological study
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Outcome_Physical
severity of PIPN
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Outcome_Adverse-effects
was summarized
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Outcome_Other
a modified Peripheral Neuropathy ( PNP ) score
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Outcome_Adverse-effects
incidence of neurotoxicity
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Outcome_Physical
relative risk ( RR ) of developing PIPN
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Outcome_Other
Mean PNP scores
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Outcome_Mental
tolerated
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Outcome_Other
safety profile
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Outcome_Physical
occurrence of paclitaxel-induced peripheral nerve damage
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Participant_Sample-size
Thirty-two
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Participant_Condition
chemotherapy
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Participant_Condition
cancer