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

Phase 2

Completed

• Conditions: Hand-foot Syndrome
• Interventions: Drug: Allopurinol; Drug: Placebo

• Registration Number: NCT01609166
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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 Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2012-05-24
• Study First Submitted QC: 2012-05-29
• Study First Posted: 2012-05-31
• Primary Completion: 2012-09
• Study Completion: 2012-12
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-22
• Last Update Posted: 2014-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients older than 18years-old,that initiate treatment with oral capecitabine, without signs of hand-feet syndrome toxicity.
• Free acceptance to participate part in this clinical trial, with signature of the form of informed assent approved for the study, writing of the volunteer.

Exclusion Criteria

• Age lower than 18 years
• Precedents of allergy, idiosyncrasy or hypersensitivity to the medicament.
• Denial of the patient to sign the informed assent.
• Any disorder or current / previous treatment that, in the opinion of the investigator, incapacitates the patient to take part in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Allopurinol 3% cream	Allopurinol	Allopurinol 3% cream in one side of the body
Placebo cream	Placebo	Placebo cream in the other side of the body

Primary Outcome Measures

Name	Time	Method
Changes in the signs of hand-foot syndrome	At 1-2-3-4-5-6 months	Erythema, descamation, vesiculation

Secondary Outcome Measures

Name	Time	Method
Changes in the symptoms of hand-foot syndrome	At 1-2-3-4-5-6 months	Burning, prurigo

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain