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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hand-foot Syndrome

Intervention / Treatment
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* Drug: Allopurinol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Allopurinol 3% cream<br>Allopurinol 3% cream in one side of the body | Drug: Allopurinol<br>* Allopurinol 3% cream application in one side of the body, twice a day for 6 months<br>|
| Placebo Comparator: Placebo cream<br>Placebo cream in the other side of the body | Drug: Placebo<br>* Placebo cream application in the other side of the body, twice a day for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the signs of hand-foot syndrome | Erythema, descamation, vesiculation | At 1-2-3-4-5-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the symptoms of hand-foot syndrome | Burning, prurigo | At 1-2-3-4-5-6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hand-foot Syndrome, capecitabine, allopurinol