Pyridoxine and Topical Urea/Lactic Acid-Based Cream in Preventing Hand-Foot Syndrome in Patients Receiving Capecitabine for Breast Cancer or Other Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

137

Participants

Timeline

Start Date

June 30, 2006

Primary Completion Date

July 31, 2009

Conditions
Breast CancerDrug/Agent Toxicity by Tissue/OrganUnspecified Adult Solid Tumor, Protocol Specific
Interventions
DIETARY_SUPPLEMENT

pyridoxine hydrochloride

Given orally

DRUG

urea/lactic acid-based topical cream

Applied topically

OTHER

placebo

Given orally or applied topically

Trial Locations (231)

18105

Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest, Allentown

22401

Fredericksburg Oncology, Incorporated, Fredericksburg

28139

Rutherford Hospital, Rutherfordton

29303

CCOP - Upstate Carolina, Spartanburg

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg

29621

AnMed Cancer Center, Anderson

32224

Mayo Clinic - Jacksonville, Jacksonville

33021

Memorial Cancer Institute at Memorial Regional Hospital, Hollywood

43015

Grady Memorial Hospital, Delaware

43055

Licking Memorial Cancer Care Program at Licking Memorial Hospital, Newark

43081

Mount Carmel St. Ann's Cancer Center, Westerville

43130

Fairfield Medical Center, Lancaster

43215

CCOP - Columbus, Columbus

Grant Medical Center Cancer Care, Columbus

43222

Mount Carmel Health - West Hospital, Columbus

43228

Doctors Hospital at Ohio Health, Columbus

43311

Mary Rutan Hospital, Bellefontaine

43402

Wood County Oncology Center, Bowling Green

43537

Northwest Ohio Oncology Center, Maumee

St. Luke's Hospital, Maumee

43560

Flower Hospital Cancer Center, Sylvania

43567

Fulton County Health Center, Wauseon

43606

Toledo Hospital, Toledo

43608

St. Vincent Mercy Medical Center, Toledo

43614

Medical University of Ohio Cancer Center, Toledo

43616

St. Charles Mercy Hospital, Oregon

Toledo Clinic - Oregon, Oregon

43617

CCOP - Toledo Community Hospital, Toledo

43623

St. Anne Mercy Hospital, Toledo

Toledo Clinic, Incorporated - Main Clinic, Toledo

43701

Genesis - Good Samaritan Hospital, Zanesville

44035

Hematology Oncology Center, Elyria

44870

North Coast Cancer Care, Incorporated, Sandusky

44883

Mercy Hospital of Tiffin, Tiffin

45177

Clinton Memorial Hospital, Wilmington

45385

Ruth G. McMillan Cancer Center at Greene Memorial Hospital, Xenia

45405

Grandview Hospital, Dayton

45406

Good Samaritan Hospital, Dayton

45409

David L. Rike Cancer Center at Miami Valley Hospital, Dayton

45415

Samaritan North Cancer Care Center, Dayton

45429

CCOP - Dayton, Dayton

Charles F. Kettering Memorial Hospital, Kettering

45504

Mercy Medical Center, Springfield

45505

Community Hospital of Springfield and Clark County, Springfield

45601

Adena Regional Medical Center, Chillicothe

45750

Strecker Cancer Center at Marietta Memorial Hospital, Marietta

45804

Lima Memorial Hospital, Lima

45840

Blanchard Valley Medical Associates, Findlay

46107

St. Francis Hospital and Health Centers - Beech Grove Campus, Beech Grove

46360

Saint Anthony Memorial Health Centers, Michigan City

46515

Elkhart General Hospital, Elkhart

46601

CCOP - Northern Indiana CR Consortium, South Bend

Memorial Hospital of South Bend, South Bend

46617

Saint Joseph Regional Medical Center, South Bend

South Bend Clinic, South Bend

46904

Howard Community Hospital, Kokomo

47374

Reid Hospital & Health Care Services, Richmond

48060

Mercy Regional Cancer Center at Mercy Hospital, Port Huron

48093

St. John Macomb Hospital, Warren

48106

CCOP - Michigan Cancer Research Consortium, Ann Arbor

48144

Haematology-Oncology Associates of Ohio and Michigan, PC, Lambertville

48154

St. Mary Mercy Hospital, Livonia

48162

Community Cancer Center of Monroe, Monroe

Mercy Memorial Hospital - Monroe, Monroe

48236

Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods

48503

Genesys Hurley Cancer Institute, Flint

Hurley Medical Center, Flint

48601

Seton Cancer Institute at Saint Mary's - Saginaw, Saginaw

49085

Lakeland Regional Cancer Care Center - St. Joseph, Saint Joseph

49201

Foote Memorial Hospital, Jackson

49221

Hickman Cancer Center at Bixby Medical Center, Adrian

49431

Green Bay Oncology, Limited - Escanaba, Escanaba

49801

Dickinson County Healthcare System, Iron Mountain

50010

McFarland Clinic, PC, Ames

50307

Mercy Capitol Hospital, Des Moines

50309

CCOP - Iowa Oncology Research Association, Des Moines

John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines

Medical Oncology and Hematology Associates at John Stoddard Cancer Center, Des Moines

50314

Medical Oncology and Hematology Associates at Mercy Cancer Center, Des Moines

Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines

50316

John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines

51101

Siouxland Hematology-Oncology Associates, LLP, Sioux City

51104

Mercy Medical Center - Sioux City, Sioux City

St. Luke's Regional Medical Center, Sioux City

52403

Cedar Rapids Oncology Associates, Cedar Rapids

Mercy Regional Cancer Center at Mercy Medical Center, Cedar Rapids

52501

McCreery Cancer Center at Ottumwa Regional, Ottumwa

52722

Bettendorf

54143

Bay Area Cancer Care Center at Bay Area Medical Center, Marinette

54154

Green Bay Oncology, Limited - Oconto Falls, Oconto Falls

54235

Green Bay Oncology, Limited - Sturgeon Bay, Sturgeon Bay

54303

Green Bay Oncology, Limited at St. Mary's Hospital, Green Bay

St. Mary's Hospital Medical Center - Green Bay, Green Bay

55101

Regions Hospital Cancer Care Center, Saint Paul

55102

HealthEast Cancer Care at St. Joseph's Hospital, Saint Paul

United Hospital, Saint Paul

55109

HealthEast Cancer Care at St. John's Hospital, Maplewood

Minnesota Oncology Hematology, PA - Maplewood, Maplewood

55125

HealthEast Cancer Care at Woodwinds Health Campus, Woodbury

Minnesota Oncology Hematology, PA - Woodbury, Woodbury

55337

Fairview Ridges Hospital, Burnsville

55350

Hutchinson Area Health Care, Hutchinson

55355

Meeker County Memorial Hospital, Lichfield

55379

St. Francis Cancer Center at St. Francis Medical Center, Shakopee

55387

Ridgeview Medical Center, Waconia

55407

Virginia Piper Cancer Institute at Abbott - Northwestern Hospital, Minneapolis

55415

Hennepin County Medical Center - Minneapolis, Minneapolis

55416

CCOP - Metro-Minnesota, Saint Louis Park

Park Nicollet Cancer Center, Saint Louis Park

55432

Mercy and Unity Cancer Center at Unity Hospital, Fridley

55433

Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids

55435

Fairview Southdale Hospital, Edina

55805

CCOP - Duluth, Duluth

Miller - Dwan Medical Center, Duluth

55905

Mayo Clinic Cancer Center, Rochester

56002

Immanuel St. Joseph's, Mankato

56007

Albert Lea Cancer Center at Albert Lea Medical Center, Albert Lea

56303

CentraCare Clinic - River Campus, Saint Cloud

Coborn Cancer Center, Saint Cloud

56308

Alexandria

56537

Fergus Falls

56601

MeritCare Bemidji, Bemidji

57105

Avera Cancer Institute, Sioux Falls

Medical X-Ray Center, PC, Sioux Falls

57701

Rapid City Regional Hospital, Rapid City

58122

MeritCare Broadway, Fargo

CCOP - MeritCare Hospital, Fargo

58201

Altru Cancer Center at Altru Hospital, Grand Forks

58501

Bismarck Cancer Center, Bismarck

Medcenter One Hospital Cancer Care Center, Bismarck

Mid Dakota Clinic, PC, Bismarck

58502

St. Alexius Medical Center Cancer Center, Bismarck

59101

CCOP - Montana Cancer Consortium, Billings

Hematology-Oncology Centers of the Northern Rockies - Billings, Billings

St. Vincent Healthcare Cancer Care Services, Billings

59405

Great Falls Clinic - Main Facility, Great Falls

Sletten Cancer Institute at Benefis Healthcare, Great Falls

Great Falls

59501

Northern Montana Hospital, Havre

59701

St. James Healthcare Cancer Care, Butte

59715

Bozeman Deaconess Cancer Center, Bozeman

59801

Community Medical Center, Missoula

59807

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula

59901

Glacier Oncology, PLLC, Kalispell

Kalispell Medical Oncology at KRMC, Kalispell

Kalispell Regional Medical Center, Kalispell

60435

Joliet Oncology-Hematology Associates, Limited - West, Joliet

60504

Rush-Copley Cancer Care Center, Aurora

61265

Trinity Cancer Center at Trinity Medical Center - 7th Street Campus, Moline

Moline

61350

Community Hospital of Ottawa, Ottawa

Oncology Hematology Associates of Central Illinois, PC - Ottawa, Ottawa

61354

Illinois Valley Community Hospital, Peru

61356

Perry Memorial Hospital, Princeton

61362

St. Margaret's Hospital, Spring Valley

61401

Galesburg Clinic, PC, Galesburg

Galesburg Cottage Hospital, Galesburg

61455

McDonough District Hospital, Macomb

61520

Graham Hospital, Canton

61530

Eureka Community Hospital, Eureka

61554

Cancer Treatment Center at Pekin Hospital, Pekin

61614

Proctor Hospital, Peoria

61615

CCOP - Illinois Oncology Research Association, Peoria

Oncology Hematology Associates of Central Illinois, PC - Peoria, Peoria

61636

Methodist Medical Center of Illinois, Peoria

61637

OSF St. Francis Medical Center, Peoria

61701

St. Joseph Medical Center, Bloomington

61747

Hopedale Medical Complex, Hopedale

61761

BroMenn Regional Medical Center, Normal

Community Cancer Center, Normal

61801

Carle Cancer Center at Carle Foundation Hospital, Urbana

CCOP - Carle Cancer Center, Urbana

62321

Memorial Hospital, Carthage

62644

Mason District Hospital, Havana

63131

Missouri Baptist Cancer Center, St Louis

63141

Arch Medical Services, Incorporated at Center for Cancer Care and Research, St Louis

66720

Cancer Center of Kansas, PA - Chanute, Chanute

67042

Cancer Center of Kansas, PA - El Dorado, El Dorado

Cancer Center of Kansas, PA - Salina, Salina

67068

Cancer Center of Kansas, PA - Kingman, Kingman

67114

Cancer Center of Kansas, PA - Newton, Newton

67124

Cancer Center of Kansas, PA - Pratt, Pratt

67152

Cancer Center of Kansas, PA - Wellington, Wellington

67156

Cancer Center of Kansas, PA - Winfield, Winfield

67208

Associates in Womens Health, PA - North Review, Wichita

Cancer Center of Kansas, PA - Medical Arts Tower, Wichita

67214

Cancer Center of Kansas, PA - Wichita, Wichita

CCOP - Wichita, Wichita

Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita

67301

Cancer Center of Kansas-Independence, Independence

67357

Cancer Center of Kansas, PA - Parsons, Parsons

67801

Cancer Center of Kansas, PA - Dodge City, Dodge City

67901

Southwest Medical Center, Liberal

68106

CCOP - Missouri Valley Cancer Consortium, Omaha

68510

Cancer Resource Center - Lincoln, Lincoln

74136

Natalie Warren Bryant Cancer Center at St. Francis Hospital, Tulsa

80012

Aurora Presbyterian Hospital, Aurora

80033

Exempla Lutheran Medical Center, Wheat Ridge

80110

Swedish Medical Center, Englewood

80124

Sky Ridge Medical Center, Lone Tree

80204

St. Anthony Central Hospital, Denver

80210

Porter Adventist Hospital, Denver

80218

Presbyterian - St. Luke's Medical Center, Denver

St. Joseph Hospital, Denver

80220

Rose Medical Center, Denver

80229

North Suburban Medical Center, Thornton

80502

Hope Cancer Care Center at Longmont United Hospital, Longmont

80539

McKee Medical Center, Loveland

80631

North Colorado Medical Center, Greeley

80933

Penrose Cancer Center at Penrose Hospital, Colorado Springs

81004

St. Mary - Corwin Regional Medical Center, Pueblo

81502

St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center, Grand Junction

85259-5499

Mayo Clinic Scottsdale, Scottsdale

80301-9019

Boulder Community Hospital, Boulder

80224-2522

CCOP - Colorado Cancer Research Program, Denver

48106-0995

Saint Joseph Mercy Cancer Center, Ann Arbor

48123-2500

Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn

48912-1811

Sparrow Regional Cancer Center, Lansing

48341-2985

St. Joseph Mercy Oakland, Pontiac

55805-1983

Duluth Clinic Cancer Center - Duluth, Duluth

55422-2900

Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center, Robbinsdale

59107-7000

Billings Clinic - Downtown, Billings

59405-5309

Big Sky Oncology, Great Falls

59807-7877

Montana Cancer Specialists at Montana Cancer Center, Missoula

68131-2197

Creighton University Medical Center, Omaha

43214-3998

Riverside Methodist Hospital Cancer Care, Columbus

45005-1066

Middletown Regional Hospital, Franklin

45373-1300

UVMC Cancer Care Center at Upper Valley Medical Center, Troy

57117-5039

Sanford Cancer Center at Sanford USD Medical Center, Sioux Falls

54301-3526

Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center, Green Bay

54307-3508

St. Vincent Hospital Regional Cancer Center, Green Bay

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Alliance for Clinical Trials in Oncology

OTHER

NCT00296036 - Pyridoxine and Topical Urea/Lactic Acid-Based Cream in Preventing Hand-Foot Syndrome in Patients Receiving Capecitabine for Breast Cancer or Other Cancer | Biotech Hunter | Biotech Hunter