ClinicalTrials.gov record
Pyridoxine and Topical Urea/Lactic Acid-Based Cream in Preventing Hand-Foot Syndrome in Patients Receiving Capecitabine for Breast Cancer or Other Cancer
ClinicalTrials.gov ID: NCT00296036
Public ClinicalTrials.gov record NCT00296036. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III Randomized, Placebo-controlled, Double-blind Trial to Determine the Effectiveness of a Urea/Lactic Acid-Based Topical Keratolytic Agent and Vitamin B-6 for Prevention of Capecitabine-Induced Hand and Foot Syndrome
Study identification
- NCT ID
- NCT00296036
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Other
- Enrollment
- 137 participants
Conditions and interventions
Conditions
Interventions
- pyridoxine hydrochloride Dietary Supplement
- urea/lactic acid-based topical cream Drug
- placebo Other
Dietary Supplement · Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2006
- Primary completion
- Jun 30, 2009
- Completion
- Not listed
- Last update posted
- Mar 15, 2017
Started 2006
United States locations
- U.S. sites
- 231
- U.S. states
- 21
- U.S. cities
- 151
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Scottsdale | Scottsdale | Arizona | 85259-5499 | — |
| Aurora Presbyterian Hospital | Aurora | Colorado | 80012 | — |
| Boulder Community Hospital | Boulder | Colorado | 80301-9019 | — |
| Penrose Cancer Center at Penrose Hospital | Colorado Springs | Colorado | 80933 | — |
| St. Anthony Central Hospital | Denver | Colorado | 80204 | — |
| Porter Adventist Hospital | Denver | Colorado | 80210 | — |
| Presbyterian - St. Luke's Medical Center | Denver | Colorado | 80218 | — |
| St. Joseph Hospital | Denver | Colorado | 80218 | — |
| Rose Medical Center | Denver | Colorado | 80220 | — |
| CCOP - Colorado Cancer Research Program | Denver | Colorado | 80224-2522 | — |
| Swedish Medical Center | Englewood | Colorado | 80110 | — |
| St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction | Colorado | 81502 | — |
| North Colorado Medical Center | Greeley | Colorado | 80631 | — |
| Sky Ridge Medical Center | Lone Tree | Colorado | 80124 | — |
| Hope Cancer Care Center at Longmont United Hospital | Longmont | Colorado | 80502 | — |
| McKee Medical Center | Loveland | Colorado | 80539 | — |
| St. Mary - Corwin Regional Medical Center | Pueblo | Colorado | 81004 | — |
| North Suburban Medical Center | Thornton | Colorado | 80229 | — |
| Exempla Lutheran Medical Center | Wheat Ridge | Colorado | 80033 | — |
| Memorial Cancer Institute at Memorial Regional Hospital | Hollywood | Florida | 33021 | — |
| Mayo Clinic - Jacksonville | Jacksonville | Florida | 32224 | — |
| Rush-Copley Cancer Care Center | Aurora | Illinois | 60504 | — |
| St. Joseph Medical Center | Bloomington | Illinois | 61701 | — |
| Graham Hospital | Canton | Illinois | 61520 | — |
| Memorial Hospital | Carthage | Illinois | 62321 | — |
| Eureka Community Hospital | Eureka | Illinois | 61530 | — |
| Galesburg Clinic, PC | Galesburg | Illinois | 61401 | — |
| Galesburg Cottage Hospital | Galesburg | Illinois | 61401 | — |
| Mason District Hospital | Havana | Illinois | 62644 | — |
| Hopedale Medical Complex | Hopedale | Illinois | 61747 | — |
| Joliet Oncology-Hematology Associates, Limited - West | Joliet | Illinois | 60435 | — |
| McDonough District Hospital | Macomb | Illinois | 61455 | — |
| Trinity Cancer Center at Trinity Medical Center - 7th Street Campus | Moline | Illinois | 61265 | — |
| Not listed | Moline | Illinois | 61265 | — |
| 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 | — |
| Cancer Treatment Center at Pekin Hospital | Pekin | Illinois | 61554 | — |
| Proctor Hospital | Peoria | Illinois | 61614 | — |
| CCOP - Illinois Oncology Research Association | Peoria | Illinois | 61615 | — |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria | Illinois | 61615 | — |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61636 | — |
| OSF St. Francis Medical Center | Peoria | Illinois | 61637 | — |
| Illinois Valley Community Hospital | Peru | Illinois | 61354 | — |
| Perry Memorial Hospital | Princeton | Illinois | 61356 | — |
| St. Margaret's Hospital | Spring Valley | Illinois | 61362 | — |
| Carle Cancer Center at Carle Foundation Hospital | Urbana | Illinois | 61801 | — |
| CCOP - Carle Cancer Center | Urbana | Illinois | 61801 | — |
| St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove | Indiana | 46107 | — |
| Elkhart General Hospital | Elkhart | Indiana | 46515 | — |
| Howard Community Hospital | Kokomo | Indiana | 46904 | — |
| Saint Anthony Memorial Health Centers | Michigan City | Indiana | 46360 | — |
| Reid Hospital & Health Care Services | Richmond | Indiana | 47374 | — |
| CCOP - Northern Indiana CR Consortium | South Bend | Indiana | 46601 | — |
| Memorial Hospital of South Bend | South Bend | Indiana | 46601 | — |
| Saint Joseph Regional Medical Center | South Bend | Indiana | 46617 | — |
| South Bend Clinic | South Bend | Indiana | 46617 | — |
| McFarland Clinic, PC | Ames | Iowa | 50010 | — |
| Not listed | Bettendorf | Iowa | 52722 | — |
| Cedar Rapids Oncology Associates | Cedar Rapids | Iowa | 52403 | — |
| Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids | Iowa | 52403 | — |
| Mercy Capitol Hospital | Des Moines | Iowa | 50307 | — |
| CCOP - Iowa Oncology Research Association | Des Moines | Iowa | 50309 | — |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | — |
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines | Iowa | 50309 | — |
| Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines | Iowa | 50314 | — |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines | Iowa | 50314 | — |
| John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines | Iowa | 50316 | — |
| McCreery Cancer Center at Ottumwa Regional | Ottumwa | Iowa | 52501 | — |
| Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa | 51101 | — |
| Mercy Medical Center - Sioux City | Sioux City | Iowa | 51104 | — |
| St. Luke's Regional Medical Center | Sioux City | Iowa | 51104 | — |
| Cancer Center of Kansas, PA - Chanute | Chanute | Kansas | 66720 | — |
| Cancer Center of Kansas, PA - Dodge City | Dodge City | Kansas | 67801 | — |
| Cancer Center of Kansas, PA - El Dorado | El Dorado | Kansas | 67042 | — |
| Cancer Center of Kansas-Independence | Independence | Kansas | 67301 | — |
| Cancer Center of Kansas, PA - Kingman | Kingman | Kansas | 67068 | — |
| Southwest Medical Center | Liberal | Kansas | 67901 | — |
| Cancer Center of Kansas, PA - Newton | Newton | Kansas | 67114 | — |
| Cancer Center of Kansas, PA - Parsons | Parsons | Kansas | 67357 | — |
| Cancer Center of Kansas, PA - Pratt | Pratt | Kansas | 67124 | — |
| Cancer Center of Kansas, PA - Salina | Salina | Kansas | 67042 | — |
| Cancer Center of Kansas, PA - Wellington | Wellington | Kansas | 67152 | — |
| Associates in Womens Health, PA - North Review | Wichita | Kansas | 67208 | — |
| Cancer Center of Kansas, PA - Medical Arts Tower | Wichita | Kansas | 67208 | — |
| Cancer Center of Kansas, PA - Wichita | Wichita | Kansas | 67214 | — |
| CCOP - Wichita | Wichita | Kansas | 67214 | — |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas | 67214 | — |
| Cancer Center of Kansas, PA - Winfield | Winfield | Kansas | 67156 | — |
| Hickman Cancer Center at Bixby Medical Center | Adrian | Michigan | 49221 | — |
| Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan | 48106-0995 | — |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan | 48106 | — |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn | Michigan | 48123-2500 | — |
| Green Bay Oncology, Limited - Escanaba | Escanaba | Michigan | 49431 | — |
| Genesys Hurley Cancer Institute | Flint | Michigan | 48503 | — |
| Hurley Medical Center | Flint | Michigan | 48503 | — |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan | 48236 | — |
| Dickinson County Healthcare System | Iron Mountain | Michigan | 49801 | — |
| Foote Memorial Hospital | Jackson | Michigan | 49201 | — |
| Haematology-Oncology Associates of Ohio and Michigan, PC | Lambertville | Michigan | 48144 | — |
| Sparrow Regional Cancer Center | Lansing | Michigan | 48912-1811 | — |
| St. Mary Mercy Hospital | Livonia | Michigan | 48154 | — |
| Community Cancer Center of Monroe | Monroe | Michigan | 48162 | — |
| Mercy Memorial Hospital - Monroe | Monroe | Michigan | 48162 | — |
| St. Joseph Mercy Oakland | Pontiac | Michigan | 48341-2985 | — |
| Mercy Regional Cancer Center at Mercy Hospital | Port Huron | Michigan | 48060 | — |
| Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw | Michigan | 48601 | — |
| Lakeland Regional Cancer Care Center - St. Joseph | Saint Joseph | Michigan | 49085 | — |
| St. John Macomb Hospital | Warren | Michigan | 48093 | — |
| Albert Lea Cancer Center at Albert Lea Medical Center | Albert Lea | Minnesota | 56007 | — |
| Not listed | Alexandria | Minnesota | 56308 | — |
| MeritCare Bemidji | Bemidji | Minnesota | 56601 | — |
| Fairview Ridges Hospital | Burnsville | Minnesota | 55337 | — |
| Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids | Minnesota | 55433 | — |
| Duluth Clinic Cancer Center - Duluth | Duluth | Minnesota | 55805-1983 | — |
| CCOP - Duluth | Duluth | Minnesota | 55805 | — |
| Miller - Dwan Medical Center | Duluth | Minnesota | 55805 | — |
| Fairview Southdale Hospital | Edina | Minnesota | 55435 | — |
| Not listed | Fergus Falls | Minnesota | 56537 | — |
| 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 | — |
| Immanuel St. Joseph's | Mankato | Minnesota | 56002 | — |
| HealthEast Cancer Care at St. John's Hospital | Maplewood | Minnesota | 55109 | — |
| Minnesota Oncology Hematology, PA - Maplewood | Maplewood | Minnesota | 55109 | — |
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis | Minnesota | 55407 | — |
| Hennepin County Medical Center - Minneapolis | Minneapolis | Minnesota | 55415 | — |
| Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale | Minnesota | 55422-2900 | — |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | — |
| CentraCare Clinic - River Campus | Saint Cloud | Minnesota | 56303 | — |
| Coborn Cancer Center | Saint Cloud | Minnesota | 56303 | — |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | — |
| Park Nicollet Cancer Center | Saint Louis Park | Minnesota | 55416 | — |
| Regions Hospital Cancer Care Center | Saint Paul | Minnesota | 55101 | — |
| HealthEast Cancer Care at St. Joseph's Hospital | Saint Paul | Minnesota | 55102 | — |
| United Hospital | Saint Paul | Minnesota | 55102 | — |
| St. Francis Cancer Center at St. Francis Medical Center | Shakopee | Minnesota | 55379 | — |
| Ridgeview Medical Center | Waconia | Minnesota | 55387 | — |
| HealthEast Cancer Care at Woodwinds Health Campus | Woodbury | Minnesota | 55125 | — |
| Minnesota Oncology Hematology, PA - Woodbury | Woodbury | Minnesota | 55125 | — |
| Missouri Baptist Cancer Center | St Louis | Missouri | 63131 | — |
| Arch Medical Services, Incorporated at Center for Cancer Care and Research | St Louis | Missouri | 63141 | — |
| CCOP - Montana Cancer Consortium | Billings | Montana | 59101 | — |
| Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana | 59101 | — |
| St. Vincent Healthcare Cancer Care Services | Billings | Montana | 59101 | — |
| Billings Clinic - Downtown | Billings | Montana | 59107-7000 | — |
| Bozeman Deaconess Cancer Center | Bozeman | Montana | 59715 | — |
| St. James Healthcare Cancer Care | Butte | Montana | 59701 | — |
| Big Sky Oncology | Great Falls | Montana | 59405-5309 | — |
| Great Falls Clinic - Main Facility | Great Falls | Montana | 59405 | — |
| Sletten Cancer Institute at Benefis Healthcare | Great Falls | Montana | 59405 | — |
| Not listed | Great Falls | Montana | 59405 | — |
| Northern Montana Hospital | Havre | Montana | 59501 | — |
| Glacier Oncology, PLLC | Kalispell | Montana | 59901 | — |
| Kalispell Medical Oncology at KRMC | Kalispell | Montana | 59901 | — |
| Kalispell Regional Medical Center | Kalispell | Montana | 59901 | — |
| Community Medical Center | Missoula | Montana | 59801 | — |
| Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana | 59807-7877 | — |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana | 59807 | — |
| Cancer Resource Center - Lincoln | Lincoln | Nebraska | 68510 | — |
| CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska | 68106 | — |
| Creighton University Medical Center | Omaha | Nebraska | 68131-2197 | — |
| Rutherford Hospital | Rutherfordton | North Carolina | 28139 | — |
| Bismarck Cancer Center | Bismarck | North Dakota | 58501 | — |
| Medcenter One Hospital Cancer Care Center | Bismarck | North Dakota | 58501 | — |
| Mid Dakota Clinic, PC | Bismarck | North Dakota | 58501 | — |
| St. Alexius Medical Center Cancer Center | Bismarck | North Dakota | 58502 | — |
| CCOP - MeritCare Hospital | Fargo | North Dakota | 58122 | — |
| MeritCare Broadway | Fargo | North Dakota | 58122 | — |
| Altru Cancer Center at Altru Hospital | Grand Forks | North Dakota | 58201 | — |
| Mary Rutan Hospital | Bellefontaine | Ohio | 43311 | — |
| Wood County Oncology Center | Bowling Green | Ohio | 43402 | — |
| Adena Regional Medical Center | Chillicothe | Ohio | 45601 | — |
| Riverside Methodist Hospital Cancer Care | Columbus | Ohio | 43214-3998 | — |
| CCOP - Columbus | Columbus | Ohio | 43215 | — |
| Grant Medical Center Cancer Care | Columbus | Ohio | 43215 | — |
| Mount Carmel Health - West Hospital | Columbus | Ohio | 43222 | — |
| Doctors Hospital at Ohio Health | Columbus | Ohio | 43228 | — |
| Grandview Hospital | Dayton | Ohio | 45405 | — |
| Good Samaritan Hospital | Dayton | Ohio | 45406 | — |
| David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio | 45409 | — |
| Samaritan North Cancer Care Center | Dayton | Ohio | 45415 | — |
| CCOP - Dayton | Dayton | Ohio | 45429 | — |
| Grady Memorial Hospital | Delaware | Ohio | 43015 | — |
| Hematology Oncology Center | Elyria | Ohio | 44035 | — |
| Blanchard Valley Medical Associates | Findlay | Ohio | 45840 | — |
| Middletown Regional Hospital | Franklin | Ohio | 45005-1066 | — |
| Charles F. Kettering Memorial Hospital | Kettering | Ohio | 45429 | — |
| Fairfield Medical Center | Lancaster | Ohio | 43130 | — |
| Lima Memorial Hospital | Lima | Ohio | 45804 | — |
| Strecker Cancer Center at Marietta Memorial Hospital | Marietta | Ohio | 45750 | — |
| Northwest Ohio Oncology Center | Maumee | Ohio | 43537 | — |
| St. Luke's Hospital | Maumee | Ohio | 43537 | — |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark | Ohio | 43055 | — |
| St. Charles Mercy Hospital | Oregon | Ohio | 43616 | — |
| Toledo Clinic - Oregon | Oregon | Ohio | 43616 | — |
| North Coast Cancer Care, Incorporated | Sandusky | Ohio | 44870 | — |
| Mercy Medical Center | Springfield | Ohio | 45504 | — |
| Community Hospital of Springfield and Clark County | Springfield | Ohio | 45505 | — |
| Flower Hospital Cancer Center | Sylvania | Ohio | 43560 | — |
| Mercy Hospital of Tiffin | Tiffin | Ohio | 44883 | — |
| Toledo Hospital | Toledo | Ohio | 43606 | — |
| St. Vincent Mercy Medical Center | Toledo | Ohio | 43608 | — |
| Medical University of Ohio Cancer Center | Toledo | Ohio | 43614 | — |
| CCOP - Toledo Community Hospital | Toledo | Ohio | 43617 | — |
| St. Anne Mercy Hospital | Toledo | Ohio | 43623 | — |
| Toledo Clinic, Incorporated - Main Clinic | Toledo | Ohio | 43623 | — |
| UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio | 45373-1300 | — |
| Fulton County Health Center | Wauseon | Ohio | 43567 | — |
| Mount Carmel St. Ann's Cancer Center | Westerville | Ohio | 43081 | — |
| Clinton Memorial Hospital | Wilmington | Ohio | 45177 | — |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio | 45385 | — |
| Genesis - Good Samaritan Hospital | Zanesville | Ohio | 43701 | — |
| Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa | Oklahoma | 74136 | — |
| Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown | Pennsylvania | 18105 | — |
| AnMed Cancer Center | Anderson | South Carolina | 29621 | — |
| CCOP - Upstate Carolina | Spartanburg | South Carolina | 29303 | — |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina | 29303 | — |
| Rapid City Regional Hospital | Rapid City | South Dakota | 57701 | — |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | — |
| Medical X-Ray Center, PC | Sioux Falls | South Dakota | 57105 | — |
| Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls | South Dakota | 57117-5039 | — |
| Fredericksburg Oncology, Incorporated | Fredericksburg | Virginia | 22401 | — |
| Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | 54301-3526 | — |
| Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay | Wisconsin | 54303 | — |
| St. Mary's Hospital Medical Center - Green Bay | Green Bay | Wisconsin | 54303 | — |
| St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | 54307-3508 | — |
| Bay Area Cancer Care Center at Bay Area Medical Center | Marinette | Wisconsin | 54143 | — |
| Green Bay Oncology, Limited - Oconto Falls | Oconto Falls | Wisconsin | 54154 | — |
| Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay | Wisconsin | 54235 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00296036, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 15, 2017 · Synced Jul 21, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00296036 live on ClinicalTrials.gov.