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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Incidence and grade of Peripheral neuropathy by common terminology criteria for adverse events v 3.0(CTCAE)and specific Ox PN gradation scales.
Within the first 45 days (plus or minus 7 days) of treatment ( 3 x oxaliplatin infusions)
Auro del Giglio, phD
Faculdade de Medicina do ABC
Brazil: National Committee of Ethics in Research