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 (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00363129
First received: August 10, 2006
Last updated: July 17, 2014
Last verified: July 2014
  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 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
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 Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Percentage of Patients With Chemotherapy-induced Sensory Peripheral Neuropathy ≥ Grade 2 [ Time Frame: 6 months post completion of chemotherapy treatment ] [ Designated as safety issue: Yes ]
    The chemotherapy-induced sensory peripheral neuropathy utilized the sensory neuropathy item from the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grading: Grade 0=none; grade 1=loss of deep tendon reflexes or paresthesia, including tingling, but not interfering with function; grade 2=objective sensory alteration or paresthesia, including tingling, interfering with function, but not with activities of daily living; grade 3=sensory alteration or paresthesia interfering with activities of daily living; grade 4=permanent sensory losses that are disabling; and grade 5=death.


Secondary Outcome Measures:
  • Percentage of Patients Requiring Dose Reductions of Chemotherapy Due to Sensory Peripheral Neuropathy [ Time Frame: 6 months post completion of chemotherapy treatment ] [ Designated as safety issue: Yes ]
  • Percentage of Patients Stopping Chemotherapy Before Treatment is Complete Due to Sensory Peripheral Neuropathy [ Time Frame: 6 months post completion of chemotherapy treatment ] [ Designated as safety issue: Yes ]
  • Time to Onset of Sensory Peripheral Neuropathy ≥ Grade 2 [ Time Frame: 6 months post completion of chemotherapy treatment ] [ Designated as safety issue: Yes ]
    Time to onset of sensory peripheral neuropathy was calculated using incidences of the adverse event while the patient was receiving chemotherapy.

  • Duration of Sensory Peripheral Neuropathy ≥ Grade 2 [ Time Frame: 6 months post completion of chemotherapy treatment ] [ Designated as safety issue: Yes ]
    Duration of sensory peripheral neuropathy is the time from onset of grade 2+ neuropathy until the neuropathy is resolved to grade 1 or less during chemotherapy treatment.


Enrollment: 207
Study Start Date: December 2006
Study Completion Date: July 2014
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:

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.

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.

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

  Eligibility

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

Required Characteristics:

  1. Scheduled to undergo curative-intent adjuvant treatment with neurotoxic chemotherapy. Patients must have had his/her tumor removed, but may have microscopic residual disease, or residual margin involvement and still be eligible.

    The patient's chemotherapy regimen must include one or more of the following neurotoxic chemotherapeutic agents: taxanes (paclitaxel, docetaxel); platinum compounds (cisplatin, carboplatin, oxaliplatin)-(oxaliplatin patients should preferentially be enrolled in protocol N04C7 while it is available).

  2. ≥ 18 years of age
  3. Ability to sign informed consent and understand the nature of a placebo-controlled trial
  4. ECOG Performance Status (PS) of 0, 1, or 2 e.g.
  5. Ability to complete questionnaire(s) by themselves or with assistance
  6. Life expectancy ≥ 6 months

Contraindications:

  1. Undergoing chemotherapy for palliative care
  2. Pre-existing history of peripheral neuropathy due to any cause (diabetes, alcohol, toxin, hereditary, etc).
  3. Prior treatment with neurotoxic chemotherapy (exception: Patient started neurotoxic chemotherapy ≤ 4 days of starting vitamin E on this study and has not been treated previously with other neurotoxic chemotherapy agents).
  4. Taking regular opioid-containing medications. (Exception: opioids, given for the short term treatment of chemotherapy-induced myalgias or arthralgias caused by taxanes are permitted.)
  5. Concurrent treatment with anticonvulsants, tricyclic antidepressants, or other neuropathic pain medications agents such as carbamazepine, phenytoin, valproic acid, gabapentin, lamotrigine, topical lidocaine patch, capsaicin cream, etc.
  6. History of coronary artery disease (i.e. MI, PTCA, or CABG ≤ 5 years or diagnosis of congestive heart failure of any NY heart class I-IV) Valve replacements are permitted as long as patient has fully recovered from the surgery.
  7. Other medical conditions, which in the opinion of the treating physician/allied health professional would make this protocol unreasonably hazardous for the patient.
  8. Vitamin E supplementation for any reason ≤ 7 days prior to randomization. (Exception:

    one multivitamin per day that contains ≤ 100 IU [mg] of Vitamin E, will be permitted.)

  9. Any of the following: pregnant women, nursing women and men or women of childbearing potential who are unwilling to employ adequate contraception
  10. Taking anticoagulant medication (i.e. coumadin, low molecular weight heparin (LMWH), or platelet aggregation inhibitors such as clopidgrel or aspirin) with the exception that 1 mg/day of coumadin for central line maintenance is allowed.
  11. Diagnosed diabetes requiring insulin or oral hypoglycemic medications
  12. Head or neck cancers
  13. Scheduled to undergo radiation therapy while on study
  14. History of hemorrhagic stroke
  15. Patients receiving neo-adjuvant therapy
  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
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Lisa Kottschade, RN, MSN, CNP Mayo Clinic
  More Information

Additional Information:
Publications:
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00363129     History of Changes
Other Study ID Numbers: NCCTG-N05C3, NCI-2011-01712, CDR0000491071
Study First Received: August 10, 2006
Results First Received: July 17, 2014
Last Updated: July 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Alliance for Clinical Trials in Oncology:
neurotoxicity
unspecified adult solid tumor, protocol specific

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

ClinicalTrials.gov processed this record on September 18, 2014