Breast Cancer
Conditions
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.
Interventions
DRUGCorticosteroids
As prescribed
DRUGPlacebo
As prescribed
DRUGcapecitabine [Xeloda]
As prescribed
DRUGdexpantenol [Bepantol]
As prescribed
Sponsors
Hoffmann-La Roche
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hand-foot syndrome onset | Event driven |
| QoL C-30 score | Weeks 7, 13 and 17 |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | Throughout study |
Countries
Brazil
Outcome results
None listed