Vitamin E for Oxaliplatin-induced Peripheral Neuropathy Prophylaxis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Felipe Melo Cruz, Faculdade de Medicina do ABC
ClinicalTrials.gov Identifier:
NCT01523574
First received: December 19, 2011
Last updated: January 29, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention Phase
Peripheral Neuropathy
Drug: Vitamin E
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized, Placebo Controlled Study of Vitamin E for Oxaliplatin-induced Neuropathy Prophylaxis

Resource links provided by NLM:


Further study details as provided by Faculdade de Medicina do ABC:

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. [ Time Frame: Within the first 45 days (plus or minus 7 days) of treatment ( 3 x oxaliplatin infusions) ] [ Designated as safety issue: Yes ]

Enrollment: 38
Study Start Date: August 2009
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control Group
Five days before chemotherapy:1 x daily Used until one week after third oxaliplatin infusion: 1 x daily
Drug: Placebo
Placebo, given orally
Other Names:
  • Calcium gluconate 1g, IV, before and after oxaliplatin
  • Magnesium sulfate 1g, IV, before and after oxaliplatin
Experimental: Vitamin e
Five days before chemotherapy:1 x daily Used until one week after third oxaliplatin infusion: 1 x daily
Drug: Vitamin E
Vitamin E 400mg PO orally
Other Names:
  • Calcium gluconate 1g, IV, before and after oxaliplatin
  • Magnesium sulfate 1g, IV, before and after oxaliplatin

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01523574

Locations
Brazil
Faculdade de Medicina do ABC
Santo Andre, Sao Paulo, Brazil, 09060-870
Faculdade de Medicina do ABC
Santo André, São Paulo, Brazil, 09060-870
Sponsors and Collaborators
Felipe Melo Cruz
Investigators
Study Director: Auro del Giglio, phD Faculdade de Medicina do ABC
  More Information

No publications provided by Faculdade de Medicina do ABC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Felipe Melo Cruz, Director, Faculdade de Medicina do ABC
ClinicalTrials.gov Identifier: NCT01523574     History of Changes
Other Study ID Numbers: VE01
Study First Received: December 19, 2011
Last Updated: January 29, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Faculdade de Medicina do ABC:
oxaliplatin
vitamin e
neuropathy
peripheral
prophylaxis

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Vitamins
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Oxaliplatin
Magnesium Sulfate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Cardiovascular Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators

ClinicalTrials.gov processed this record on September 16, 2014