Vitamin E for Oxaliplatin-induced Peripheral Neuropathy Prophylaxis

January 29, 2012 updated by: Felipe Melo Cruz

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • Santo Andre, Sao Paulo, Brazil, 09060-870
        • Faculdade de Medicina do ABC
    • São Paulo
      • Santo André, São Paulo, Brazil, 09060-870
        • Faculdade de Medicina do ABC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control Group
Five days before chemotherapy:1 x daily Used until one week after third oxaliplatin infusion: 1 x daily
Drug: Placebo
Placebo, given orally
Other Names:
  • Calcium gluconate 1g, IV, before and after oxaliplatin
  • Magnesium sulfate 1g, IV, before and after oxaliplatin
Experimental: Vitamin e
Five days before chemotherapy:1 x daily Used until one week after third oxaliplatin infusion: 1 x daily
Drug: Vitamin E
Vitamin E 400mg PO orally
Other Names:
  • Calcium gluconate 1g, IV, before and after oxaliplatin
  • Magnesium sulfate 1g, IV, before and after oxaliplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Within the first 45 days (plus or minus 7 days) of treatment ( 3 x oxaliplatin infusions)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Felipe Melo Cruz

Investigators

  • Study Director: Auro del Giglio, phD, Faculdade de Medicina do ABC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

December 19, 2011

First Submitted That Met QC Criteria

January 29, 2012

First Posted (Estimate)

February 1, 2012

Study Record Updates

Last Update Posted (Estimate)

February 1, 2012

Last Update Submitted That Met QC Criteria

January 29, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VE01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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