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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
| |
| 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corticosteroids | Drug | As prescribed |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Hand-foot syndrome onset | Event driven | |
| QoL C-30 score | Weeks 7, 13 and 17 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Throughout study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortaleza | Ceará | 60336-550 | Brazil | |||
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| Drug |
As prescribed |
|
| capecitabine [Xeloda] | Drug | As prescribed |
|
| dexpantenol [Bepantol] | Drug | As prescribed |
|
| Salvador |
| Estado de Bahia |
| 41810-570 |
| Brazil |
| Salvador, Bahia | Estado de Bahia | 40170-380 | Brazil |
| Taguatinga | Federal District | 72115-700 | Brazil |
| Goiânia | Goiás | 74605-020 | Brazil |
| Goiânia | Goiás | 74605-070 | Brazil |
| Belo Horizonte | Minas Gerais | 30150-320 | Brazil |
| Belo Horizonte | Minas Gerais | 31190-131 | Brazil |
| Teresina | Piauí | 90430-001 | Brazil |
| Niterói | Rio de Janeiro | 24033-900 | Brazil |
| Rio de Janeiro | Rio de Janeiro | 21020130 | Brazil |
| Rio de Janeiro | Rio de Janeiro | 22745-130 | Brazil |
| Natal | Rio Grande do Norte | 59040150 | Brazil |
| Caxias do Sul | Rio Grande do Sul | 95020-170 | Brazil |
| Caxias do Sul | Rio Grande do Sul | 95070-560 | Brazil |
| Ijuí | Rio Grande do Sul | 98700-000 | Brazil |
| Lajeado | Rio Grande do Sul | 95900-000 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90430-001 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Itajaí | Santa Catarina | 88301-220 | Brazil |
| Barretos | São Paulo | 14784-400 | Brazil |
| Campinas | São Paulo | 13083-888 | Brazil |
| Jaú | São Paulo | 17210-080 | Brazil |
| Ribeirão Preto | São Paulo | 14048-900 | Brazil |
| Santo André | São Paulo | 09060-650 | Brazil |
| Santos | São Paulo | 11075-350 | Brazil |
| Santos | São Paulo | 11075-900 | Brazil |
| São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| São Paulo | São Paulo | 01221-020 | Brazil |
| São Paulo | São Paulo | 04026-000 | Brazil |
| São Paulo | São Paulo | 04039-901 | Brazil |
| São Paulo | São Paulo | 22793-080 | Brazil |
| Sorocaba | São Paulo | 18030-005 | Brazil |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D000069287 | Capecitabine |
| D010205 | Pantothenic Acid |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D007094 | Imides |
| D009930 | Organic Chemicals |
| D015091 | beta-Alanine |
| D000409 | Alanine |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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