Phase
Condition
Neurologic Disorders
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Required Characteristics:
- 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).
≥ 18 years of age
Ability to sign informed consent and understand the nature of a placebo-controlled trial
ECOG Performance Status (PS) of 0, 1, or 2 e.g.
Ability to complete questionnaire(s) by themselves or with assistance
Life expectancy ≥ 6 months
Contraindications:
Undergoing chemotherapy for palliative care
Pre-existing history of peripheral neuropathy due to any cause (diabetes, alcohol, toxin, hereditary, etc).
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).
Taking regular opioid-containing medications. (Exception: opioids, given for the short term treatment of chemotherapy-induced myalgias or arthralgias caused by taxanes are permitted.)
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.
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.
Other medical conditions, which in the opinion of the treating physician/allied health professional would make this protocol unreasonably hazardous for the patient.
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.)
Any of the following: pregnant women, nursing women and men or women of childbearing potential who are unwilling to employ adequate contraception
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.
Diagnosed diabetes requiring insulin or oral hypoglycemic medications
Head or neck cancers
Scheduled to undergo radiation therapy while on study
History of hemorrhagic stroke
Patients receiving neo-adjuvant therapy
Study Design
Study Description
Connect with a study center
St. Joseph Medical Center
Bloomington, Illinois 61701
United StatesSite Not Available
Graham Hospital
Canton, Illinois 61520
United StatesSite Not Available
Memorial Hospital
Carthage, Illinois 62321
United StatesSite Not Available
Eureka Community Hospital
Eureka, Illinois 61530
United StatesSite Not Available
Galesburg Clinic, PC
Galesburg, Illinois 61401
United StatesSite Not Available
Galesburg Cottage Hospital
Galesburg, Illinois 61401
United StatesSite Not Available
Mason District Hospital
Havana, Illinois 62644
United StatesSite Not Available
Hopedale Medical Complex
Hopedale, Illinois 61747
United StatesSite Not Available
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois 60435
United StatesSite Not Available
Kewanee Hospital
Kewanee, Illinois 61443
United StatesSite Not Available
BroMenn Regional Medical Center
Normal, Illinois 61761
United StatesSite Not Available
Community Cancer Center
Normal, Illinois 61761
United StatesSite Not Available
Community Hospital of Ottawa
Ottawa, Illinois 61350
United StatesSite Not Available
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois 61350
United StatesSite Not Available
CCOP - Illinois Oncology Research Association
Peoria, Illinois 61615
United StatesSite Not Available
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois 61615
United StatesSite Not Available
Perry Memorial Hospital
Princeton, Illinois 61356
United StatesSite Not Available
CCOP - Carle Cancer Center
Urbana, Illinois 61801
United StatesSite Not Available
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois 61801
United StatesSite Not Available
Saint Anthony Memorial Health Centers
Michigan City, Indiana 46360
United StatesSite Not Available
McCreery Cancer Center at Ottumwa Regional
Ottumwa, Iowa 52501
United StatesSite Not Available
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa 51101
United StatesSite Not Available
St. Luke's Regional Medical Center
Sioux City, Iowa 51104
United StatesSite Not Available
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan 48106
United StatesSite Not Available
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan 48106-0995
United StatesSite Not Available
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan 48123-2500
United StatesSite Not Available
Genesys Hurley Cancer Institute
Flint, Michigan 48503
United StatesSite Not Available
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan 48236
United StatesSite Not Available
Foote Memorial Hospital
Jackson, Michigan 49201
United StatesSite Not Available
Sparrow Regional Cancer Center
Lansing, Michigan 48912-1811
United StatesSite Not Available
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan 48601
United StatesSite Not Available
St. John Macomb Hospital
Warren, Michigan 48093
United StatesSite Not Available
Fairview Ridges Hospital
Burnsville, Minnesota 55337
United StatesSite Not Available
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota 55433
United StatesSite Not Available
Fairview Southdale Hospital
Edina, Minnesota 55435
United StatesSite Not Available
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota 55432
United StatesSite Not Available
Hutchinson Area Health Care
Hutchinson, Minnesota 55350
United StatesSite Not Available
Meeker County Memorial Hospital
Lichfield, Minnesota 55355
United StatesSite Not Available
Immanuel St. Joseph's
Mankato, Minnesota 56002
United StatesSite Not Available
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota 55109
United StatesSite Not Available
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota 55109
United StatesSite Not Available
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota 55415
United StatesSite Not Available
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota 55407
United StatesSite Not Available
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota 55416
United StatesSite Not Available
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota 55379
United StatesSite Not Available
HealthEast Cancer Care at St. Joseph's Hospital
St Paul, Minnesota 55102
United StatesSite Not Available
United Hospital
St. Paul, Minnesota 55102
United StatesSite Not Available
HealthEast Cancer Care at Woodwinds Health Campus
Woodbury, Minnesota 55125
United StatesSite Not Available
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota 55125
United StatesSite Not Available
Bismarck Cancer Center
Bismarck, North Dakota 58501
United StatesSite Not Available
Medcenter One Hospital Cancer Care Center
Bismarck, North Dakota 58501
United StatesSite Not Available
Mid Dakota Clinic, PC
Bismarck, North Dakota 58501
United StatesSite Not Available
Adena Regional Medical Center
Chillicothe, Ohio 45601
United StatesSite Not Available
CCOP - Columbus
Columbus, Ohio 43215
United StatesSite Not Available
Doctors Hospital at Ohio Health
Columbus, Ohio 43228
United StatesSite Not Available
Grant Riverside Cancer Services
Columbus, Ohio 43215
United StatesSite Not Available
Mount Carmel Health - West Hospital
Columbus, Ohio 43222
United StatesSite Not Available
Riverside Methodist Hospital Cancer Care
Columbus, Ohio 43214-3998
United StatesSite Not Available
Grady Memorial Hospital
Delaware, Ohio 43015
United StatesSite Not Available
Fairfield Medical Center
Lancaster, Ohio 43130
United StatesSite Not Available
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio 45750
United StatesSite Not Available
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio 43055
United StatesSite Not Available
Community Hospital of Springfield and Clark County
Springfield, Ohio 45505
United StatesSite Not Available
Mercy Medical Center
Springfield, Ohio 45504
United StatesSite Not Available
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio 43081
United StatesSite Not Available
Genesis - Good Samaritan Hospital
Zanesville, Ohio 43701
United StatesSite Not Available
Avera Cancer Institute
Sioux Falls, South Dakota 57105
United StatesSite Not Available
Medical X-Ray Center, PC
Sioux Falls, South Dakota 57105
United StatesSite Not Available
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota 57117-5039
United StatesSite Not Available


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