Vitamin E for Oxaliplatin-induced Peripheral Neuropathy Prophylaxis

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Felipe Melo Cruz
• Treatments: alpha-Tocopherol; Calcium; Calcium, Dietary; Magnesium Sulfate; Oxaliplatin; Tocopherols; Tocotrienols; Vitamin E; Vitamins

Criteria

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