Vitamin E for Oxaliplatin-induced Peripheral Neuropathy Prophylaxis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Peripheral Neuropathy

Intervention / Treatment
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* Drug: Vitamin E
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group<br>Five days before chemotherapy:1 x daily Used until one week after third oxaliplatin infusion: 1 x daily | Drug: Placebo<br>* Placebo, given orally<br>* Other names: Magnesium sulfate 1g, IV, before and after oxaliplatin;|
| Experimental: Vitamin e<br>Five days before chemotherapy:1 x daily Used until one week after third oxaliplatin infusion: 1 x daily | Drug: Vitamin E<br>* Vitamin E 400mg PO orally<br>* Other names: Magnesium sulfate 1g, IV, before and after oxaliplatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oxaliplatin, vitamin e, neuropathy, peripheral, prophylaxis