Status:
COMPLETED
A Study of Prophylactic Treatment for Hand-Foot Syndrome in Patients Treated With Oral Xeloda (Capecitabine).
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This 3 arm study will compare the prophylactic effect of topical corticosteroids, Bepantol or placebo on hand-foot syndrome in patients receiving Xeloda for treatment of metastatic breast cancer, meta...
Eligibility Criteria
Inclusion
- 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
- existence of clinical symptoms suggesting hand-foot syndrome;
- use of doxorubicin, 5-FU and/or cytarabine for last 3 months;
- diabetes mellitus.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
598 Patients enrolled
Trial Details
Trial ID
NCT00661102
Start Date
December 1 2008
End Date
April 1 2011
Last Update
November 2 2016
Active Locations (35)
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1
Fortaleza, Ceará, Brazil, 60336-550
2
Salvador, Estado de Bahia, Brazil, 41810-570
3
Salvador, Bahia, Estado de Bahia, Brazil, 40170-380
4
Taguatinga, Federal District, Brazil, 72115-700