title: Vitamin E for prevention of oxaliplatin-induced peripheral neuropathy: a pilot randomized clinical trial.
abstract: CONTEXT AND OBJECTIVE Oxaliplatin is one of the chemotherapy regimens most used for treating colorectal cancer. One of the main limitations to its use is induction of peripheral neuropathy. Previous studies have shown that vitamin E can reduce the incidence of peripheral neuropathy by 50%. This study aimed to assess the effectiveness of vitamin E for prevention of oxaliplatin-induced peripheral neuropathy. DESIGN AND SETTING Prospective, phase II, randomized pilot study developed at a university hospital in the Greater ABC region. METHODS Patients were randomized five days before starting oxaliplatin treatment, to receive either vitamin E or placebo until the end of the chemotherapy regimen. The outcome was evaluated using the Common Terminology Criteria for Adverse Events (CTCAE), version 3, and specific gradation scales for oxaliplatin-induced peripheral neuropathy. Patients with colorectal and gastric cancer who had been scheduled to receive oxaliplatin-based chemotherapy were included. Both groups received calcium and magnesium supplementation before and after oxaliplatin infusions. RESULTS Eighteen patients were randomized to the vitamin E group and 16 to the placebo group. Cumulative incidence of 83% with peripheral neuropathy grades 1/2 was observed in the vitamin E group, versus 68% in the placebo group (P = 0.45). A trend towards more diarrhea was observed among patients who received vitamin E (55.6% vs. 18.8%; P = 0.06). There were no other significant differences in toxicity between the groups. CONCLUSIONS No significant decrease in the incidence of acute oxaliplatin-induced peripheral neuropathy was demonstrated through vitamin E use.
authors.affiliation: Department of Hematology and Oncology, Faculdade de Medicina do ABC, Fundação ABC, Santo André, São Paulo, Brazil.
authors.forename: Samuel Oliveira de
authors.initials: SO
authors.lastname: Afonseca
authors.forename: Felipe Melo
authors.initials: FM
authors.lastname: Cruz
authors.forename: Daniel de Iracema Gomes
authors.initials: Dde I
authors.lastname: Cubero
authors.forename: Andrea Thaumaturgo
authors.initials: AT
authors.lastname: Lera
authors.forename: Fernanda
authors.initials: F
authors.lastname: Schindler
authors.forename: Marcia
authors.initials: M
authors.lastname: Okawara
authors.forename: Luiz Fernando de
authors.initials: LF
authors.lastname: Souza
authors.forename: Nataly Pimentel
authors.initials: NP
authors.lastname: Rodrigues
authors.forename: Auro del
authors.initials: Ad
authors.lastname: Giglio
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects*; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000009:adverse effects*; D000077150:Oxaliplatin; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced / Q000517:prevention & control*; D010865:Pilot Projects; D011446:Prospective Studies; D014810:Vitamin E / Q000627:therapeutic use*; D014815:Vitamins / Q000627:therapeutic use*
chemical_list: D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D014815:Vitamins; D000077150:Oxaliplatin; D014810:Vitamin E
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