NCT01523574

Vitamin E for Oxaliplatin-induced Peripheral Neuropathy Prophylaxis

Randomized, Placebo Controlled Study of Vitamin E for Oxaliplatin-induced Neuropathy Prophylaxis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Felipe Melo Cruz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Peripheral Neuropathy

Interventions

Type	Name	Description
DRUG	Vitamin E	Vitamin E 400mg PO orally
DRUG	Placebo	Placebo, given orally

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-11-01
• Completion: 2010-12-01
• First posted: 2012-02-01
• Last updated: 2012-02-01

Locations

1 site across 1 country: Brazil