Back to resultsVitamin E for Oxaliplatin-induced Peripheral Neuropathy Prophylaxis
Primary Purpose
Peripheral Neuropathy
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Vitamin E
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Peripheral Neuropathy focused on measuring oxaliplatin, vitamin e, neuropathy, peripheral, prophylaxis
Eligibility 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
Sites / Locations
- Faculdade de Medicina do ABC
- Faculdade de Medicina do ABC
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control Group
Vitamin e
Arm Description
Five days before chemotherapy:1 x daily Used until one week after third oxaliplatin infusion: 1 x daily
Five days before chemotherapy:1 x daily Used until one week after third oxaliplatin infusion: 1 x daily
Outcomes
Primary Outcome Measures
Incidence and grade of Peripheral neuropathy by common terminology criteria for adverse events v 3.0(CTCAE)and specific Ox PN gradation scales.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01523574
Brief Title
Vitamin E for Oxaliplatin-induced Peripheral Neuropathy Prophylaxis
Official Title
Randomized, Placebo Controlled Study of Vitamin E for Oxaliplatin-induced Neuropathy Prophylaxis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Felipe Melo Cruz
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
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-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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathy
Keywords
oxaliplatin, vitamin e, neuropathy, peripheral, prophylaxis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Five days before chemotherapy:1 x daily Used until one week after third oxaliplatin infusion: 1 x daily
Arm Title
Vitamin e
Arm Type
Experimental
Arm Description
Five days before chemotherapy:1 x daily Used until one week after third oxaliplatin infusion: 1 x daily
Intervention Type
Drug
Intervention Name(s)
Vitamin E
Other Intervention Name(s)
Calcium gluconate 1g, IV, before and after oxaliplatin, Magnesium sulfate 1g, IV, before and after oxaliplatin
Intervention Description
Vitamin E 400mg PO orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Calcium gluconate 1g, IV, before and after oxaliplatin, Magnesium sulfate 1g, IV, before and after oxaliplatin
Intervention Description
Placebo, given orally
Primary Outcome Measure Information:
Title
Incidence and grade of Peripheral neuropathy by common terminology criteria for adverse events v 3.0(CTCAE)and specific Ox PN gradation scales.
Time Frame
Within the first 45 days (plus or minus 7 days) of treatment ( 3 x oxaliplatin infusions)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Auro del Giglio, phD
Organizational Affiliation
Faculdade de Medicina do ABC
Official's Role
Study Director
Facility Information:
Facility Name
Faculdade de Medicina do ABC
City
Santo Andre
State/Province
Sao Paulo
ZIP/Postal Code
09060-870
Country
Brazil
Facility Name
Faculdade de Medicina do ABC
City
Santo André
State/Province
São Paulo
ZIP/Postal Code
09060-870
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
23538593
Citation
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.
Results Reference
derived
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Vitamin E for Oxaliplatin-induced Peripheral Neuropathy Prophylaxis
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