ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00363129
Recruitment Status : Completed
First Posted : August 15, 2006
Results First Posted : August 8, 2014
Last Update Posted : July 6, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

August 10, 2006
August 15, 2006
July 17, 2014
August 8, 2014
July 6, 2016
December 2006
December 2010   (Final data collection date for primary outcome measure)
Percentage of Patients With Chemotherapy-induced Sensory Peripheral Neuropathy ≥ Grade 2 [ Time Frame: 6 months post completion of chemotherapy treatment ]
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.
Not Provided
Complete list of historical versions of study NCT00363129 on ClinicalTrials.gov Archive Site
  • Percentage of Patients Requiring Dose Reductions of Chemotherapy Due to Sensory Peripheral Neuropathy [ Time Frame: 6 months post completion of chemotherapy treatment ]
  • Percentage of Patients Stopping Chemotherapy Before Treatment is Complete Due to Sensory Peripheral Neuropathy [ Time Frame: 6 months post completion of chemotherapy treatment ]
  • Time to Onset of Sensory Peripheral Neuropathy ≥ Grade 2 [ Time Frame: 6 months post completion of chemotherapy treatment ]
    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 ]
    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.
Not Provided
Not Provided
Not Provided
 
Vitamin E in Preventing Peripheral Neuropathy Caused by Chemotherapy in Patients Receiving Chemotherapy for Cancer
The Use of Vitamin E for Prevention of Chemotherapy Induced Peripheral Neuropathy: A Phase III Double-Blind Placebo Controlled Study

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
  • Neurotoxicity
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Dietary Supplement: vitamin E
    Given orally
  • Other: placebo
    Given orally
  • 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.
    Intervention: Dietary Supplement: vitamin E
  • 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.
    Intervention: Other: placebo
Kottschade LA, Sloan JA, Mazurczak MA, Johnson DB, Murphy BP, Rowland KM, Smith DA, Berg AR, Stella PJ, Loprinzi CL. The use of vitamin E for the prevention of chemotherapy-induced peripheral neuropathy: results of a randomized phase III clinical trial. Support Care Cancer. 2011 Nov;19(11):1769-77. doi: 10.1007/s00520-010-1018-3. Epub 2010 Oct 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
207
Not Provided
August 2014
December 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00363129
NCCTG-N05C3
NCI-2011-01712 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000491071 ( Registry Identifier: PDQ (Physician Data Query) )
No
Not Provided
Not Provided
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Lisa Kottschade, RN, MSN, CNP Mayo Clinic
Alliance for Clinical Trials in Oncology
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP