Vitamin E for Oxaliplatin-induced Peripheral Neuropathy Prophylaxis

Felipe Melo Cruz38 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Peripheral Neuropathy

Interventions

Vitamin EDRUG

Vitamin E 400mg PO orally

PlaceboDRUG

Placebo, given orally

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Faculdade de Medicina do ABC

Santo André, São Paulo, Brazil

Outcomes

Primary Outcomes

Incidence and grade of Peripheral neuropathy by common terminology criteria for adverse events v 3.0(CTCAE)and specific Ox PN gradation scales.

Time frame: Within the first 45 days (plus or minus 7 days) of treatment ( 3 x oxaliplatin infusions)

Data from ClinicalTrials.gov

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