Vitamin E for Oxaliplatin-induced Peripheral Neuropathy Prophylaxis

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

Full Title of Study: “Randomized, Placebo Controlled Study of Vitamin E for Oxaliplatin-induced Neuropathy Prophylaxis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 2010

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.

Interventions

  • Drug: Vitamin E
    • Vitamin E 400mg PO orally
  • Drug: Placebo
    • Placebo, given orally

Arms, Groups and Cohorts

  • Placebo Comparator: Control Group
    • Five days before chemotherapy:1 x daily Used until one week after third oxaliplatin infusion: 1 x daily
  • Experimental: Vitamin e
    • Five days before chemotherapy:1 x daily Used until one week after third oxaliplatin infusion: 1 x daily

Clinical Trial Outcome Measures

Primary Measures

  • 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Felipe Melo Cruz
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Felipe Melo Cruz, Director – Faculdade de Medicina do ABC
  • Overall Official(s)
    • Auro del Giglio, phD, Study Director, Faculdade de Medicina do ABC

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