Spots Global Cancer Trial Database for Vitamin E in Preventing Peripheral Neuropathy Caused by Chemotherapy in Patients Receiving Chemotherapy for Cancer
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Trial Identification
Brief Title: Vitamin E in Preventing Peripheral Neuropathy Caused by Chemotherapy in Patients Receiving Chemotherapy for Cancer
Official Title: The Use of Vitamin E for Prevention of Chemotherapy Induced Peripheral Neuropathy: A Phase III Double-Blind Placebo Controlled Study
Study ID: NCT00363129
Study Description
Brief 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.
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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
St. Joseph Medical Center, Bloomington, Illinois, United States
Graham Hospital, Canton, Illinois, United States
Memorial Hospital, Carthage, Illinois, United States
Eureka Community Hospital, Eureka, Illinois, United States
Galesburg Clinic, PC, Galesburg, Illinois, United States
Galesburg Cottage Hospital, Galesburg, Illinois, United States
Mason District Hospital, Havana, Illinois, United States
Hopedale Medical Complex, Hopedale, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West, Joliet, Illinois, United States
Kewanee Hospital, Kewanee, Illinois, United States
BroMenn Regional Medical Center, Normal, Illinois, United States
Community Cancer Center, Normal, Illinois, United States
Community Hospital of Ottawa, Ottawa, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa, Ottawa, Illinois, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria, Peoria, Illinois, United States
Perry Memorial Hospital, Princeton, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital, Urbana, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
Saint Anthony Memorial Health Centers, Michigan City, Indiana, United States
McCreery Cancer Center at Ottumwa Regional, Ottumwa, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa, United States
St. Luke's Regional Medical Center, Sioux City, Iowa, United States
Saint Joseph Mercy Cancer Center, Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn, Michigan, United States
Genesys Hurley Cancer Institute, Flint, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, United States
Foote Memorial Hospital, Jackson, Michigan, United States
Sparrow Regional Cancer Center, Lansing, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw, Saginaw, Michigan, United States
St. John Macomb Hospital, Warren, Michigan, United States
Fairview Ridges Hospital, Burnsville, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids, Minnesota, United States
Fairview Southdale Hospital, Edina, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital, Fridley, Minnesota, United States
Hutchinson Area Health Care, Hutchinson, Minnesota, United States
Meeker County Memorial Hospital, Lichfield, Minnesota, United States
Immanuel St. Joseph's, Mankato, Minnesota, United States
HealthEast Cancer Care at St. John's Hospital, Maplewood, Minnesota, United States
Minnesota Oncology Hematology, PA - Maplewood, Maplewood, Minnesota, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital, Minneapolis, Minnesota, United States
Hennepin County Medical Center - Minneapolis, Minneapolis, Minnesota, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
St. Francis Cancer Center at St. Francis Medical Center, Shakopee, Minnesota, United States
HealthEast Cancer Care at St. Joseph's Hospital, St Paul, Minnesota, United States
United Hospital, St. Paul, Minnesota, United States
HealthEast Cancer Care at Woodwinds Health Campus, Woodbury, Minnesota, United States
Minnesota Oncology Hematology, PA - Woodbury, Woodbury, Minnesota, United States
Bismarck Cancer Center, Bismarck, North Dakota, United States
Medcenter One Hospital Cancer Care Center, Bismarck, North Dakota, United States
Mid Dakota Clinic, PC, Bismarck, North Dakota, United States
Adena Regional Medical Center, Chillicothe, Ohio, United States
Riverside Methodist Hospital Cancer Care, Columbus, Ohio, United States
CCOP - Columbus, Columbus, Ohio, United States
Grant Riverside Cancer Services, Columbus, Ohio, United States
Mount Carmel Health - West Hospital, Columbus, Ohio, United States
Doctors Hospital at Ohio Health, Columbus, Ohio, United States
Grady Memorial Hospital, Delaware, Ohio, United States
Fairfield Medical Center, Lancaster, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital, Marietta, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital, Newark, Ohio, United States
Mercy Medical Center, Springfield, Ohio, United States
Community Hospital of Springfield and Clark County, Springfield, Ohio, United States
Mount Carmel St. Ann's Cancer Center, Westerville, Ohio, United States
Genesis - Good Samaritan Hospital, Zanesville, Ohio, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Medical X-Ray Center, PC, Sioux Falls, South Dakota, United States
Sanford Cancer Center at Sanford USD Medical Center, Sioux Falls, South Dakota, United States
Contact Details
Name: Lisa Kottschade, RN, MSN, CNP
Affiliation: Mayo Clinic
Role: STUDY_CHAIR
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