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Completed

NCT Number: NCT01523574

Vitamin E for Oxaliplatin-induced Peripheral 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

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Key information

Conditions

Peripheral Neuropathy Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculdade de Medicina do ABC

Santo André, São Paulo, 09060-870, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin E

Drug

Vitamin E 400mg PO orally

Other names: Calcium gluconate 1g, IV, before and after oxaliplatin, Magnesium sulfate 1g, IV, before and after oxaliplatin

Placebo

Drug

Placebo, given orally

Other names: Calcium gluconate 1g, IV, before and after oxaliplatin, Magnesium sulfate 1g, IV, before and after oxaliplatin

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Felipe Melo Cruz

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 1, 2012
Registry last updated
Feb 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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