Vitamin E in Preventing Peripheral Neuropathy Caused by Chemotherapy in Patients Receiving Chemotherapy for Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00363129
First received: August 10, 2006
Last updated: May 10, 2012
Last verified: January 2009
  Purpose

RATIONALE: Vitamin E may prevent peripheral neuropathy caused by chemotherapy in patients with cancer. It is not yet known whether vitamin E is more effective than a placebo in preventing peripheral neuropathy caused by chemotherapy in patients receiving chemotherapy for cancer.

PURPOSE: This randomized phase III trial is studying vitamin E to see how well it works compared with a placebo in preventing peripheral neuropathy caused by chemotherapy in patients receiving chemotherapy for cancer.


Condition Intervention Phase
Neurotoxicity
Unspecified Adult Solid Tumor, Protocol Specific
Dietary Supplement: vitamin E
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Supportive Care
Official Title: The Use of Vitamin E for Prevention of Chemotherapy Induced Peripheral Neuropathy: A Phase III Double-Blind Placebo Controlled Study

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Percentage of patients with chemotherapy-induced sensory peripheral neuropathy ≥ grade 2 as measured by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of patients requiring dose reductions of chemotherapy due to sensory peripheral neuropathy [ Designated as safety issue: Yes ]
  • Proportion of patients stopping chemotherapy before treatment is complete due to sensory peripheral neuropathy [ Designated as safety issue: Yes ]
  • Toxicity of vitamin E [ Designated as safety issue: Yes ]
  • Time to onset of sensory peripheral neuropathy ≥ grade 2 [ Designated as safety issue: Yes ]
  • Average duration of sensory peripheral neuropathy ≥ grade 2 [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: December 2006
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
Dietary Supplement: vitamin E
Given orally
Placebo Comparator: Arm II
Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
Other: placebo
Given orally

Detailed Description:

OBJECTIVES:

Primary

  • Compare the incidence of chemotherapy-induced sensory peripheral neuropathy ≥ grade 2 in patients undergoing curative neurotoxic chemotherapy for cancer treated with vitamin E vs placebo.

Secondary

  • Compare the proportion of patients requiring dose reductions of chemotherapy secondary to sensory peripheral neuropathy.
  • Compare the proportion of patients stopping chemotherapy before treatment is complete secondary to sensory peripheral neuropathy.
  • Assess the toxicity of vitamin E in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to type of chemotherapy (taxane vs cisplatin vs carboplatin vs oxaliplatin vs combination), age (≤ 50 years vs > 50 years), and gender. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
  • Arm II: Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.

After completion of study treatment, patients are followed at 6 months.

PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Scheduled to undergo curative-intent adjuvant neurotoxic chemotherapy for cancer

    • Regimen must include ≥ 1 of the following neurotoxic chemotherapeutic agents:

      • Taxanes (e.g., paclitaxel or docetaxel)
      • Platinum compounds (e.g., cisplatin, carboplatin, or oxaliplatin*) NOTE: *Patients receiving oxaliplatin should preferentially be enrolled in protocol NCCTG-N04C7
  • No preexisting or history of peripheral neuropathy due to any cause (e.g., diabetes, alcohol, toxin, or hereditary)
  • Must have resected tumor with or without microscopic residual disease or residual margin involvement
  • No head and neck cancers

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 6 months
  • Able to complete questionnaire(s) alone or with assistance
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No history of coronary artery disease, including, any of the following:

    • Myocardial infarction within the past 5 years
    • Percutaneous transluminal coronary angioplasty within the past 5 years
    • Coronary artery bypass graft within the past 5 years
    • New York Heart Association class I-IV congestive heart failure
  • No other medical conditions that would contraindicate study therapy
  • No history of hemorrhagic stroke
  • No diabetes requiring insulin or oral hypoglycemic medications

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Prior valve replacement surgery allowed provided patient has fully recovered from the surgery
  • No prior neurotoxic chemotherapy unless the following criteria are met:

    • Patient has started neurotoxic chemotherapy within 4 days of starting vitamin E on this study
    • Patient has not been previously treated with other neurotoxic chemotherapy agents
  • No vitamin E supplementation within 7 days prior to randomization (except for 1 multivitamin per day that contains ≤ 100 mg of vitamin E)
  • No concurrent neoadjuvant therapy
  • No concurrent chemotherapy for palliative care
  • No concurrent regular opioid-containing medications

    • Opioids for short-term treatment of chemotherapy-induced myalgias or arthralgias caused by taxanes allowed
  • No concurrent anticonvulsants, tricyclic antidepressants, or other neuropathic pain medications (e.g., carbamazepine, phenytoin, valproic acid, gabapentin, lamotrigine, topical lidocaine patch, or capsaicin cream)
  • No concurrent anticoagulant medication (e.g., warfarin, low molecular weight heparin, or platelet-aggregation inhibitors, such as clopidgrel or acetylsalicylic acid)

    • 1 mg/day of warfarin for central line maintenance is allowed
  • No planned concurrent radiotherapy
  • No other concurrent therapy for chemotherapy-induced peripheral neuropathy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00363129

  Show 69 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Investigator: Lisa Kottschade, RN, MSN, CNP Mayo Clinic
Investigator: Miroslaw A. Mazurczak, MD, MP Sanford Cancer Center at Sanford USD Medical Center
Investigator: Charles L. Loprinzi, MD Mayo Clinic
Investigator: DeAnne Smith, RN, CNP Mayo Clinic
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00363129     History of Changes
Other Study ID Numbers: CDR0000491071, NCCTG-N05C3
Study First Received: August 10, 2006
Last Updated: May 10, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
neurotoxicity
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Neurotoxicity Syndromes
Neuromuscular Diseases
Nervous System Diseases
Poisoning
Substance-Related Disorders
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 16, 2014