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

Phase 2
18 Years
Not Enrolling
Peripheral Neuropathy

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Trial Information

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

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.

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

- Patients currently receiving gabapentin, carbamazepine, amitriptyline, amifostine or

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

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

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Auro del Giglio, phD

Investigator Role:

Study Director

Investigator Affiliation:

Faculdade de Medicina do ABC


Brazil: National Committee of Ethics in Research

Study ID:




Start Date:

August 2009

Completion Date:

December 2010

Related Keywords:

  • Peripheral Neuropathy
  • oxaliplatin
  • vitamin e
  • neuropathy
  • peripheral
  • prophylaxis
  • Peripheral Nervous System Diseases
  • Demyelinating Diseases
  • Polyneuropathies
  • Nerve Compression Syndromes
  • Neurologic Manifestations
  • Neurotoxicity Syndromes