Vitamin E for Oxaliplatin-induced Peripheral Neuropathy Prophylaxis

Status Completed

Clinical Trial Summary

Introduction: Oxaliplatin (Ox) is a frequently used platinum-based medication that is a part of many chemotherapy regimens for the treatment of several gastrointestinal malignancies. One of the most important limitations to its use is the induction of both acute and chronic peripheral neuropathy (PN). Previous studies have shown that vitamin E can reduce the incidence of cisplatin-induced PN by 50%. In this study, the investigators aimed to determine if vitamin E could also prevent Ox-induced acute PN

Clinical Trial Description

This was a prospective, phase II, randomized pilot study. Patients were randomized 5 days before the start of Ox to receive either vitamin E at 400 mg daily or placebo, until after the end of the Ox-based chemotherapy regimen. The investigators evaluated PN intensity using the CTCAE version 3 and specific Ox PN gradation scales. The investigators included patients with colorectal and gastric cancers scheduled to receive Ox-based chemotherapy. Both groups received calcium and magnesium supplements before and after oxaliplatin infusions. ;

Study Design

Related Conditions & MeSH terms

Peripheral Nervous System Diseases
Peripheral Neuropathy

Clinical Trial Details

NCT number	NCT01523574
Study type	Interventional
Source	Faculdade de Medicina do ABC
Contact
Status	Completed
Phase	Phase 2
Start date	August 2009
Completion date	December 2010

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