A Randomized, Open Label Study Comparing the Efficacy of Topical Corticosteroids or Bepantol in the Prophylaxis of Hand-foot Syndrome in Patients Receiving Oral Xeloda for Treatment of Metastatic Breast Cancer or Colorectal Cancer.
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Breast Cancer
Both
Breast Cancer
Trial Information
A Randomized, Open Label Study Comparing the Efficacy of Topical Corticosteroids or Bepantol in the Prophylaxis of Hand-foot Syndrome in Patients Receiving Oral Xeloda for Treatment of Metastatic Breast Cancer or Colorectal Cancer.
Inclusion Criteria:
- adult patients, >=18 years of age;
- breast cancer or colorectal cancer patients;
- treated with oral Xeloda for <=5 days;
- lack of hand-foot syndrome (palmar-plantar erythrodysesthesia).
Exclusion Criteria:
- existence of clinical symptoms suggesting hand-foot syndrome;
- use of doxorubicin, 5-FU and/or cytarabine for last 3 months;
- diabetes mellitus.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Hand-foot syndrome onset
Outcome Time Frame:
Event driven
Safety Issue:
Yes
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Brazil: Ministry of Health
Study ID:
ML21419
NCT ID:
NCT00661102
Start Date:
December 2008
Completion Date:
April 2011
Related Keywords:
- Breast Cancer
- Breast Neoplasms
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