Vitamin E for Oxaliplatin-induced Peripheral Neuropathy Prophylaxis
Randomized, Placebo Controlled Study of Vitamin E for Oxaliplatin-induced Neuropathy Prophylaxis
1 other identifier
interventional
38
1 country
1
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 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2009
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 19, 2011
CompletedFirst Posted
Study publicly available on registry
February 1, 2012
CompletedFebruary 1, 2012
January 1, 2012
1.3 years
December 19, 2011
January 29, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (2)
Control Group
PLACEBO COMPARATORFive days before chemotherapy:1 x daily Used until one week after third oxaliplatin infusion: 1 x daily
Vitamin e
EXPERIMENTALFive days before chemotherapy:1 x daily Used until one week after third oxaliplatin infusion: 1 x daily
Interventions
Vitamin E 400mg PO orally
Placebo, given orally
Eligibility Criteria
You may qualify if:
- ECOG Performance status 0 or 1
- Older than 18 years
- New diagnose with colorectal or gastric cancer
- Scheduled to receive oxaliplatin-based regimens
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Felipe Melo Cruzlead
Study Sites (1)
Faculdade de Medicina do ABC
Santo André, São Paulo, 09060-870, Brazil
Related Publications (1)
Afonseca SO, Cruz FM, Cubero Dde I, Lera AT, Schindler F, Okawara M, Souza LF, Rodrigues NP, Giglio Ad. Vitamin E for prevention of oxaliplatin-induced peripheral neuropathy: a pilot randomized clinical trial. Sao Paulo Med J. 2013;131(1):35-8. doi: 10.1590/s1516-31802013000100006.
PMID: 23538593DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Auro del Giglio, phD
Faculdade de Medicina do ABC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
December 19, 2011
First Posted
February 1, 2012
Study Start
August 1, 2009
Primary Completion
November 1, 2010
Study Completion
December 1, 2010
Last Updated
February 1, 2012
Record last verified: 2012-01