Vitamin E for Oxaliplatin-induced Peripheral Neuropathy Prophylaxis

Peripheral Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01523574
• Other study ID #: VE01
• Status: Completed
• Phase: Phase 2
• First received: December 19, 2011
• Last updated: January 29, 2012
• Start date: August 2009
• Est. completion date: December 2010

Study information

• Verified date: January 2012
• Source: Faculdade de Medicina do ABC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

Drug:
• Vitamin E
Vitamin E 400mg PO orally
• Placebo
Placebo, given orally

Locations

Country	Name	City	State
Brazil	Faculdade de Medicina do ABC	Santo Andre	Sao Paulo
Brazil	Faculdade de Medicina do ABC	Santo André	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Felipe Melo Cruz

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)