NCT01609166

Effectiveness Allopurinol Topical Agent Prevention Capecitabine-induced Hand-foot Syndrome

Placebo-controlled Trial to Determine the Effectiveness of a 3% Allopurinol-base Topical Agent for Prevention of Capecitabine-induced Hand-foot Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hand-foot Syndrome

Interventions

Type	Name	Description
DRUG	Allopurinol	Allopurinol 3% cream application in one side of the body, twice a day for 6 months
DRUG	Placebo	Placebo cream application in the other side of the body, twice a day for 6 months

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-09-01
• Completion: 2012-12-01
• First posted: 2012-05-31
• Last updated: 2014-05-23

Locations

1 site across 1 country: Spain