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, 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.

Neuropatia Periférica em Pacientes com Câncer Colorretal em Tratamento com Oxaliplatina

“…Diversos autores observaram a relação desses sintomas sensitivos com o frio 1,5,8,10,17,20,21 . Em ensaio clíni-co 20 4,18,19,28,29 .…”

Assessment and Treatment of Chemotherapy-induced Peripheral Neuropathy- a Physical Therapy Perspective

“…It also possesses generalized neuroprotective and neurotrophic properties [56] and thus is useful as a preventive agent for CIPN. Vitamin-E [57], Cytokines and growth factors [58] were also reported to be effective preventive agents.…”

Pharmacological Approaches and Natural Products for Prevention of Chemotherapy-Induced Peripheral Neuropathy - A Review

“…However, a phase III study showed that Vitamin E did not appear to reduce the incidence of sensory neuropathy in patients receiving taxanes, platinum compounds, or combination [32]. More encouraging results were obtained with the administration of all-trans retinoic acid in an animal model and patients with lung cancer [33].…”