Vitamin E for Oxaliplatin-induced Peripheral Neuropathy Prophylaxis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-12-31

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

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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.

Conditions

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Peripheral Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control Group

Five days before chemotherapy:1 x daily Used until one week after third oxaliplatin infusion: 1 x daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo, given orally

Vitamin e

Five days before chemotherapy:1 x daily Used until one week after third oxaliplatin infusion: 1 x daily

Group Type EXPERIMENTAL

Vitamin E

Intervention Type DRUG

Vitamin E 400mg PO orally

Interventions

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Vitamin E

Vitamin E 400mg PO orally

Intervention Type DRUG

Placebo

Placebo, given orally

Intervention Type DRUG

Other Intervention Names

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Calcium gluconate 1g, IV, before and after oxaliplatin Magnesium sulfate 1g, IV, before and after oxaliplatin Calcium gluconate 1g, IV, before and after oxaliplatin Magnesium sulfate 1g, IV, before and after oxaliplatin

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No