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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
598
As prescribed
As prescribed
As prescribed
As prescribed
Unnamed facility
Fortaleza, Ceará, Brazil
Unnamed facility
Salvador, Estado de Bahia, Brazil
Unnamed facility
Salvador, Bahia, Estado de Bahia, Brazil
Unnamed facility
Taguatinga, Federal District, Brazil
Unnamed facility
Goiânia, Goiás, Brazil
Unnamed facility
Goiânia, Goiás, Brazil
Unnamed facility
Belo Horizonte, Minas Gerais, Brazil
Unnamed facility
Belo Horizonte, Minas Gerais, Brazil
Unnamed facility
Teresina, Piauí, Brazil
Unnamed facility
Niterói, Rio de Janeiro, Brazil
...and 25 more locations
Hand-foot syndrome onset
Time frame: Event driven
QoL C-30 score
Time frame: Weeks 7, 13 and 17
Adverse events
Time frame: Throughout study
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