Vitamin E for Oxaliplatin-induced Peripheral Neuropathy Prophylaxis

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01523574

Enrollment

Registered

2012-02-01

Start date

2009-08-31

Completion date

2010-12-31

Last updated

2012-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Neuropathy

Keywords

oxaliplatin, vitamin e, neuropathy, peripheral, prophylaxis

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.

Interventions

DRUGVitamin E

Vitamin E 400mg PO orally

DRUGPlacebo

Placebo, given orally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	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)

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026