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
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: 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 July 22, 2014