Status:
COMPLETED
Vitamin E for Oxaliplatin-induced Peripheral Neuropathy Prophylaxis
Lead Sponsor:
Felipe Melo Cruz
Conditions:
Peripheral Neuropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 i...
Detailed 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-b...
Eligibility Criteria
Inclusion
- ECOG Performance status 0 or 1
- Older than 18 years
- New diagnose with colorectal or gastric cancer
- Scheduled to receive oxaliplatin-based regimens
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01523574
Start Date
August 1 2009
End Date
December 1 2010
Last Update
February 1 2012
Active Locations (1)
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1
Faculdade de Medicina do ABC
Santo André, São Paulo, Brazil, 09060-870