Status:
COMPLETED
Pyridoxine and Topical Urea/Lactic Acid-Based Cream in Preventing Hand-Foot Syndrome in Patients Receiving Capecitabine for Breast Cancer or Other Cancer
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Drug/Agent Toxicity by Tissue/Organ
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 witho...
Detailed Description
OBJECTIVES: * Determine whether the prophylactic use of a topical urea/lactic acid cream can decrease the incidence/severity of capecitabine-caused palmar-plantar erythrodysesthesia in patients recei...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed breast and/or other cancer
- Undergoing first treatment with capecitabine as adjuvant (including neo-adjuvant) therapy OR for metastatic disease
- Receiving a dose of capecitabine either 2,000 mg/day (1,000 mg twice daily) OR 2,500 mg/day for 14 days with 4 courses of therapy at 3 week (+/- 3 days) intervals
- Hormone-receptor status not specified
- PATIENT CHARACTERISTICS:
- Male or female
- Menopausal status not specified
- No history of allergy to urea-containing cream
- No pre-existing neuropathy ≥ grade 2
- No other dermatologic condition, that, in the opinion of the physician, may affect the hands or feet or may complicate evaluation during study treatment
- PRIOR CONCURRENT THERAPY:
- No other concurrent agents that function to prevent palmar-plantar erythrodysesthesia caused by capecitabine or topical agents in the hands or feet for other indications (e.g., dryness)
- No concurrent vitamin B6 \> 50 mg/day
- No concurrent or planned use of over-the-counter products that contain urea or lactic acid, including any of the following:
- Aqua Care®
- Medicated Calamine\^® lotion (0.3%)
- Coppertone\^® Waterproof Ultra Protection Sunblock
- Dr. Scholl's\^® Smooth Touch deep moisturizing cream
- Depicure\^® So Smooth Cream
- Dove\^® Moisturizing Cream Wash
- Cetaphil\^ ®Moisturizing Cream
- Vaseline Intensive Care \^ ® lotion
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT00296036
Start Date
June 1 2006
Last Update
March 16 2017
Active Locations (231)
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1
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
2
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
3
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019
4
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933