Pyridoxine and Topical Urea/Lactic Acid-Based Cream in Preventing Hand-Foot Syndrome in Patients Receiving Capecitabine for Breast Cancer or Other Cancer
Completed · Phase 3 · Has a placebo group
Conditions studied: Breast Cancer, Drug/Agent Toxicity by Tissue/Organ, Unspecified Adult Solid Tumor, Protocol Specific
In brief
RATIONALE: Pyridoxine (vitamin B6) and topical urea/lactic acid-based cream may prevent or lessen hand-foot syndrome caused by chemotherapy. It is not yet known whether giving pyridoxine with or without topical urea/lactic acid-based cream is more effective than topical urea/lactic acid-based cream alone or a placebo in preventing hand-foot syndrome. PURPOSE: This randomized phase III trial is studying pyridoxine and topical urea/lactic acid-based cream to see how well they work compared with giving pyridoxine together with a placebo, giving topical urea/lactic acid-based cream together with a placebo, or giving two placebos in preventing hand-foot syndrome in patients who are receiving capecitabine for breast cancer or other cancer.
Key facts
- Study ID
- NCT00296036
- Run by
- Alliance for Clinical Trials in Oncology
- People needed
- 137
- Starts
- 2006-06-01
- Last updated by the study team
- 2017-03-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Aurora Presbyterian Hospital — Aurora, Colorado, United States
- Boulder Community Hospital — Boulder, Colorado, United States
- Penrose Cancer Center at Penrose Hospital — Colorado Springs, Colorado, United States
- St. Anthony Central Hospital — Denver, Colorado, United States
- Porter Adventist Hospital — Denver, Colorado, United States
- Presbyterian - St. Luke's Medical Center — Denver, Colorado, United States
- St. Joseph Hospital — Denver, Colorado, United States
- Rose Medical Center — Denver, Colorado, United States
- CCOP - Colorado Cancer Research Program — Denver, Colorado, United States
- Swedish Medical Center — Englewood, Colorado, United States
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center — Grand Junction, Colorado, United States
- North Colorado Medical Center — Greeley, Colorado, United States
- Sky Ridge Medical Center — Lone Tree, Colorado, United States
- Hope Cancer Care Center at Longmont United Hospital — Longmont, Colorado, United States
- McKee Medical Center — Loveland, Colorado, United States
- St. Mary - Corwin Regional Medical Center — Pueblo, Colorado, United States
- North Suburban Medical Center — Thornton, Colorado, United States
- Exempla Lutheran Medical Center — Wheat Ridge, Colorado, United States
- Memorial Cancer Institute at Memorial Regional Hospital — Hollywood, Florida, United States
- Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
- Rush-Copley Cancer Care Center — Aurora, Illinois, United States
- St. Joseph Medical Center — Bloomington, Illinois, United States
- Graham Hospital — Canton, Illinois, United States
- Memorial Hospital — Carthage, Illinois, United States
- Mayo Clinic Scottsdale — Scottsdale, Arizona, United States
Full record on ClinicalTrials.gov
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