Clinical Trial: Effectiveness Allopurinol Topical Agent Prevention Capecitabine-induced Hand-foot Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Current Primary Outcome: Changes in the signs of hand-foot syndrome [ Time Frame: At 1-2-3-4-5-6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Changes in the symptoms of hand-foot syndrome [ Time Frame: At 1-2-3-4-5-6 months ]

Original Secondary Outcome: Same as current

Information By: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Dates:
Date Received: May 24, 2012
Date Started: July 2011
Date Completion:
Last Updated: May 22, 2014
Last Verified: May 2014