Vitamin E for Oxaliplatin-induced Peripheral Neuropathy Prophylaxis

Felipe Melo Cruz

Status and phase

Completed

Phase 2

Conditions

Peripheral Neuropathy

Treatments

Drug: Vitamin E

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01523574

VE01

Details and patient eligibility

About

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 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.

Enrollment

38 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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