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

Last updated: July 1, 2016
Sponsor: Alliance for Clinical Trials in Oncology
Overall Status: Completed

Phase

3

Condition

Neurologic Disorders

Treatment

N/A

Clinical Study ID

NCT00363129
NCCTG-N05C3
NCI-2011-01712
CDR0000491071
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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).

  1. ≥ 18 years of age

  2. Ability to sign informed consent and understand the nature of a placebo-controlled trial

  3. ECOG Performance Status (PS) of 0, 1, or 2 e.g.

  4. Ability to complete questionnaire(s) by themselves or with assistance

  5. 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.)

  1. Any of the following: pregnant women, nursing women and men or women of childbearing potential who are unwilling to employ adequate contraception

  2. 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.

  3. Diagnosed diabetes requiring insulin or oral hypoglycemic medications

  4. Head or neck cancers

  5. Scheduled to undergo radiation therapy while on study

  6. History of hemorrhagic stroke

  7. Patients receiving neo-adjuvant therapy

Study Design

Total Participants: 207
Study Start date:
December 01, 2006
Estimated Completion Date:
August 31, 2014

Study 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.

Connect with a study center

  • St. Joseph Medical Center

    Bloomington, Illinois 61701
    United States

    Site Not Available

  • Graham Hospital

    Canton, Illinois 61520
    United States

    Site Not Available

  • Memorial Hospital

    Carthage, Illinois 62321
    United States

    Site Not Available

  • Eureka Community Hospital

    Eureka, Illinois 61530
    United States

    Site Not Available

  • Galesburg Clinic, PC

    Galesburg, Illinois 61401
    United States

    Site Not Available

  • Galesburg Cottage Hospital

    Galesburg, Illinois 61401
    United States

    Site Not Available

  • Mason District Hospital

    Havana, Illinois 62644
    United States

    Site Not Available

  • Hopedale Medical Complex

    Hopedale, Illinois 61747
    United States

    Site Not Available

  • Joliet Oncology-Hematology Associates, Limited - West

    Joliet, Illinois 60435
    United States

    Site Not Available

  • Kewanee Hospital

    Kewanee, Illinois 61443
    United States

    Site Not Available

  • BroMenn Regional Medical Center

    Normal, Illinois 61761
    United States

    Site Not Available

  • Community Cancer Center

    Normal, Illinois 61761
    United States

    Site Not Available

  • Community Hospital of Ottawa

    Ottawa, Illinois 61350
    United States

    Site Not Available

  • Oncology Hematology Associates of Central Illinois, PC - Ottawa

    Ottawa, Illinois 61350
    United States

    Site Not Available

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois 61615
    United States

    Site Not Available

  • Oncology Hematology Associates of Central Illinois, PC - Peoria

    Peoria, Illinois 61615
    United States

    Site Not Available

  • Perry Memorial Hospital

    Princeton, Illinois 61356
    United States

    Site Not Available

  • CCOP - Carle Cancer Center

    Urbana, Illinois 61801
    United States

    Site Not Available

  • Carle Cancer Center at Carle Foundation Hospital

    Urbana, Illinois 61801
    United States

    Site Not Available

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana 46360
    United States

    Site Not Available

  • McCreery Cancer Center at Ottumwa Regional

    Ottumwa, Iowa 52501
    United States

    Site Not Available

  • Siouxland Hematology-Oncology Associates, LLP

    Sioux City, Iowa 51101
    United States

    Site Not Available

  • St. Luke's Regional Medical Center

    Sioux City, Iowa 51104
    United States

    Site Not Available

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan 48106
    United States

    Site Not Available

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan 48106-0995
    United States

    Site Not Available

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan 48123-2500
    United States

    Site Not Available

  • Genesys Hurley Cancer Institute

    Flint, Michigan 48503
    United States

    Site Not Available

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan 48236
    United States

    Site Not Available

  • Foote Memorial Hospital

    Jackson, Michigan 49201
    United States

    Site Not Available

  • Sparrow Regional Cancer Center

    Lansing, Michigan 48912-1811
    United States

    Site Not Available

  • Seton Cancer Institute at Saint Mary's - Saginaw

    Saginaw, Michigan 48601
    United States

    Site Not Available

  • St. John Macomb Hospital

    Warren, Michigan 48093
    United States

    Site Not Available

  • Fairview Ridges Hospital

    Burnsville, Minnesota 55337
    United States

    Site Not Available

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota 55433
    United States

    Site Not Available

  • Fairview Southdale Hospital

    Edina, Minnesota 55435
    United States

    Site Not Available

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota 55432
    United States

    Site Not Available

  • Hutchinson Area Health Care

    Hutchinson, Minnesota 55350
    United States

    Site Not Available

  • Meeker County Memorial Hospital

    Lichfield, Minnesota 55355
    United States

    Site Not Available

  • Immanuel St. Joseph's

    Mankato, Minnesota 56002
    United States

    Site Not Available

  • HealthEast Cancer Care at St. John's Hospital

    Maplewood, Minnesota 55109
    United States

    Site Not Available

  • Minnesota Oncology Hematology, PA - Maplewood

    Maplewood, Minnesota 55109
    United States

    Site Not Available

  • Hennepin County Medical Center - Minneapolis

    Minneapolis, Minnesota 55415
    United States

    Site Not Available

  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota 55416
    United States

    Site Not Available

  • St. Francis Cancer Center at St. Francis Medical Center

    Shakopee, Minnesota 55379
    United States

    Site Not Available

  • HealthEast Cancer Care at St. Joseph's Hospital

    St Paul, Minnesota 55102
    United States

    Site Not Available

  • United Hospital

    St. Paul, Minnesota 55102
    United States

    Site Not Available

  • HealthEast Cancer Care at Woodwinds Health Campus

    Woodbury, Minnesota 55125
    United States

    Site Not Available

  • Minnesota Oncology Hematology, PA - Woodbury

    Woodbury, Minnesota 55125
    United States

    Site Not Available

  • Bismarck Cancer Center

    Bismarck, North Dakota 58501
    United States

    Site Not Available

  • Medcenter One Hospital Cancer Care Center

    Bismarck, North Dakota 58501
    United States

    Site Not Available

  • Mid Dakota Clinic, PC

    Bismarck, North Dakota 58501
    United States

    Site Not Available

  • Adena Regional Medical Center

    Chillicothe, Ohio 45601
    United States

    Site Not Available

  • CCOP - Columbus

    Columbus, Ohio 43215
    United States

    Site Not Available

  • Doctors Hospital at Ohio Health

    Columbus, Ohio 43228
    United States

    Site Not Available

  • Grant Riverside Cancer Services

    Columbus, Ohio 43215
    United States

    Site Not Available

  • Mount Carmel Health - West Hospital

    Columbus, Ohio 43222
    United States

    Site Not Available

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio 43214-3998
    United States

    Site Not Available

  • Grady Memorial Hospital

    Delaware, Ohio 43015
    United States

    Site Not Available

  • Fairfield Medical Center

    Lancaster, Ohio 43130
    United States

    Site Not Available

  • Strecker Cancer Center at Marietta Memorial Hospital

    Marietta, Ohio 45750
    United States

    Site Not Available

  • Licking Memorial Cancer Care Program at Licking Memorial Hospital

    Newark, Ohio 43055
    United States

    Site Not Available

  • Community Hospital of Springfield and Clark County

    Springfield, Ohio 45505
    United States

    Site Not Available

  • Mercy Medical Center

    Springfield, Ohio 45504
    United States

    Site Not Available

  • Mount Carmel St. Ann's Cancer Center

    Westerville, Ohio 43081
    United States

    Site Not Available

  • Genesis - Good Samaritan Hospital

    Zanesville, Ohio 43701
    United States

    Site Not Available

  • Avera Cancer Institute

    Sioux Falls, South Dakota 57105
    United States

    Site Not Available

  • Medical X-Ray Center, PC

    Sioux Falls, South Dakota 57105
    United States

    Site Not Available

  • Sanford Cancer Center at Sanford USD Medical Center

    Sioux Falls, South Dakota 57117-5039
    United States

    Site Not Available

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