The Use of Vitamin E for Prevention of Chemotherapy Induced Peripheral Neuropathy: A Phase III Double-Blind Placebo Controlled Study
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.
Interventional
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Percentage of patients with chemotherapy-induced sensory peripheral neuropathy ≥ grade 2 as measured by NCI CTCAE v3.0
Yes
Lisa Kottschade, RN, MSN, CNP
Mayo Clinic
United States: Federal Government
CDR0000491071
NCT00363129
December 2006
Name | Location |
---|---|
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Joliet Oncology-Hematology Associates, Limited - West | Joliet, Illinois 60435 |
Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
St. John Macomb Hospital | Warren, Michigan 48093 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
Meeker County Memorial Hospital | Lichfield, Minnesota 55355 |
Minnesota Oncology Hematology, PA - Maplewood | Maplewood, Minnesota 55109 |
HealthEast Cancer Care at St. John's Hospital | Maplewood, Minnesota 55109 |
Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis, Minnesota 55407 |
St. Francis Cancer Center at St. Francis Medical Center | Shakopee, Minnesota 55379 |
HealthEast Cancer Care at St. Joseph's Hospital | St Paul, Minnesota 55102 |
United Hospital | St. Paul, Minnesota 55102 |
Minnesota Oncology Hematology, PA - Woodbury | Woodbury, Minnesota 55125 |
HealthEast Cancer Care at Woodwinds Health Campus | Woodbury, Minnesota 55125 |
Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls, South Dakota 57117-5039 |
Medical X-Ray Center, PC | Sioux Falls, South Dakota 57105 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
CCOP - Columbus | Columbus, Ohio 43206 |
McCreery Cancer Center at Ottumwa Regional | Ottumwa, Iowa 52501 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Doctors Hospital at Ohio Health | Columbus, Ohio 43228 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
Grant Riverside Cancer Services | Columbus, Ohio 43215 |
Grady Memorial Hospital | Delaware, Ohio 43015 |
Fairfield Medical Center | Lancaster, Ohio 43130 |
Strecker Cancer Center at Marietta Memorial Hospital | Marietta, Ohio 45750 |
Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark, Ohio 43055 |
Community Hospital of Springfield and Clark County | Springfield, Ohio 45505 |
Genesis - Good Samaritan Hospital | Zanesville, Ohio 43701 |
Mount Carmel Health - West Hospital | Columbus, Ohio 43222 |
St. Joseph Medical Center | Bloomington, Illinois 61701 |
Graham Hospital | Canton, Illinois 61520 |
Memorial Hospital | Carthage, Illinois 62321 |
Eureka Community Hospital | Eureka, Illinois 61530 |
Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
Mason District Hospital | Havana, Illinois 62644 |
Hopedale Medical Complex | Hopedale, Illinois 61747 |
Kewanee Hospital | Kewanee, Illinois 61443 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Community Cancer Center | Normal, Illinois 61761 |
Community Hospital of Ottawa | Ottawa, Illinois 61350 |
Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa, Illinois 61350 |
Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria, Illinois 61615 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
Bismarck Cancer Center | Bismarck, North Dakota 58501 |
Mercy Medical Center | Springfield, Ohio 45504 |
Foote Memorial Hospital | Jackson, Michigan 49201 |
Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw, Michigan 48601 |
Mount Carmel St. Ann's Cancer Center | Westerville, Ohio 43081 |
Mid Dakota Clinic, PC | Bismarck, North Dakota 58501 |
Galesburg Clinic, PC | Galesburg, Illinois 61401 |
Medcenter One Hospital Cancer Care Center | Bismarck, North Dakota 58501 |
Immanuel St. Joseph's | Mankato, Minnesota 56002 |