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 withneurotoxic 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.
RCT Entities:
BACKGROUND: Chemotherapy-induced peripheral neuropathy (CIPN) continues to be a substantial problem for many cancerpatients. 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+ SNtoxicity 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.
Authors: M D Stubblefield; L T Vahdat; C M Balmaceda; A B Troxel; C S Hesdorffer; C L Gooch Journal: Clin Oncol (R Coll Radiol) Date: 2005-06 Impact factor: 4.126
Authors: Ravi D Rao; Patrick J Flynn; Jeff A Sloan; Gilbert Y Wong; Paul Novotny; David B Johnson; Howard M Gross; Samer I Renno; Mohammed Nashawaty; Charles L Loprinzi Journal: Cancer Date: 2008-06-15 Impact factor: 6.860
Authors: Harry Openshaw; Karen Beamon; Timothy W Synold; Jeff Longmate; Neal E Slatkin; James H Doroshow; Stephen Forman; Kim Margolin; Robert Morgan; Stephen Shibata; George Somlo Journal: Clin Cancer Res Date: 2004-01-15 Impact factor: 12.531
Authors: David H Moore; James Donnelly; William P McGuire; Lois Almadrones; David F Cella; Thomas J Herzog; Steven E Waggoner Journal: J Clin Oncol Date: 2003-11-15 Impact factor: 44.544
Authors: Neil Majithia; Sarah M Temkin; Kathryn J Ruddy; Andreas S Beutler; Dawn L Hershman; Charles L Loprinzi Journal: Support Care Cancer Date: 2015-12-19 Impact factor: 3.603
Authors: Jennifer Le-Rademacher; Rahul Kanwar; Drew Seisler; Deirdre R Pachman; Rui Qin; Alexej Abyzov; Kathryn J Ruddy; Michaela S Banck; Ellen M Lavoie Smith; Susan G Dorsey; Neil K Aaronson; Jeff Sloan; Charles L Loprinzi; Andreas S Beutler Journal: Support Care Cancer Date: 2017-06-20 Impact factor: 3.603
Authors: Gary R Zirpoli; Susan E McCann; Lara E Sucheston-Campbell; Dawn L Hershman; Gregory Ciupak; Warren Davis; Joseph M Unger; Halle C F Moore; James A Stewart; Claudine Isaacs; Timothy J Hobday; Muhammad Salim; Gabriel N Hortobagyi; Julie R Gralow; G Thomas Budd; Kathy S Albain; Christine B Ambrosone Journal: J Natl Cancer Inst Date: 2017-12-01 Impact factor: 13.506