Hand-foot syndrome (HFS) is a dose-limiting toxicity of capecitabine for which no effective
preventative treatment has been definitively demonstrated. This trial is conducted on the
basis of preliminary data that a 3% allopurinol-based topical agent may prevent HFS.
A randomized, double-blind phase III trial will evaluate 40 patients receiving their first
ever cycle of capecitabine at a dose of either 2,000 or 2,500 mg/m2 per day for 14 days.
Patients will be randomly assigned to a 3% allopurinol versus a placebo cream, which will be
applied to the hands and feet twice per day for 6 months after the start of capecitabine.
Patients will be examined every month and the investigators will take some photographs of
hands and feet. HFS toxicity grade (Common Terminology Criteria for Adverse Events
[CTCAE]v3.0) will be also collected at baseline and at the end of each cycle. The primary end
point is the incidence of moderate/severe HFS symptoms at the end of capecitabine treatment ,
based on the patient-reported dermatological exploration.
Phase:
Phase 2
Details
Lead Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau