A Study of Prophylactic Treatment for Hand-Foot Syndrome in Patients Treated With Oral Xeloda (Capecitabine).
Phase 3
Completed
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00661102
- Lead Sponsor
- Hoffmann-La Roche
- 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, metastatic colorectal cancer or adjuvant treatment of colorectal cancer. Patients who have been receiving oral Xeloda for at least 5 days will be randomized to receive prophylactic treatment with either placebo, topical corticosteroids or Bepantol. The anticipated time on study treatment is until disease progression or development of hand-foot syndrome, and the target sample size is 500+ individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 598
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).
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Exclusion Criteria
- existence of clinical symptoms suggesting hand-foot syndrome;
- use of doxorubicin, 5-FU and/or cytarabine for last 3 months;
- diabetes mellitus.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 capecitabine [Xeloda] - 1 capecitabine [Xeloda] - 1 dexpantenol [Bepantol] - 2 Corticosteroids - 3 Placebo - 3 capecitabine [Xeloda] -
- Primary Outcome Measures
Name Time Method Hand-foot syndrome onset Event driven QoL C-30 score Weeks 7, 13 and 17
- Secondary Outcome Measures
Name Time Method Adverse events Throughout study