Vitamin E for Oxaliplatin-induced Peripheral Neuropathy Prophylaxis

Phase 2

Completed

• Conditions: Peripheral Neuropathy
• Interventions: Drug: Placebo; Drug: Vitamin E

• Registration Number: NCT01523574
• Lead Sponsor: Felipe Melo Cruz

Brief 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.

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2010-11
• Study Completion: 2010-12
• Study First Submitted: 2011-12-19
• Status Verified: 2012-01
• Study First Submitted QC: 2012-01-29
• Last Update Submitted: 2012-01-29
• Study First Posted: 2012-02-01
• Last Update Posted: 2012-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• ECOG Performance status 0 or 1
• Older than 18 years
• New diagnose with colorectal or gastric cancer
• Scheduled to receive oxaliplatin-based regimens

Exclusion Criteria

• Excluded patients with a previous history of PN or with symptomatic PN at entry into the study
• Excluded patients who received other chemotherapy regimens (except isolated 5-fluorouracil)
• Patients currently receiving gabapentin, carbamazepine, amitriptyline, amifostine or multivitamins

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Placebo	Five days before chemotherapy:1 x daily Used until one week after third oxaliplatin infusion: 1 x daily
Vitamin e	Vitamin E	Five days before chemotherapy:1 x daily Used until one week after third oxaliplatin infusion: 1 x daily

Primary Outcome Measures

Name	Time	Method
Incidence and grade of Peripheral neuropathy by common terminology criteria for adverse events v 3.0(CTCAE)and specific Ox PN gradation scales.	Within the first 45 days (plus or minus 7 days) of treatment ( 3 x oxaliplatin infusions)

Trial Locations

Locations (1)

Faculdade de Medicina do ABC; 🇧🇷 Santo André, São Paulo, Brazil