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

This study has been completed.
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Identifier:
First received: May 24, 2012
Last updated: May 22, 2014
Last verified: May 2014

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.

Condition Intervention Phase
Hand-foot Syndrome
Drug: Allopurinol
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Placebo-controlled Trial to Determine the Effectiveness of a 3% Allopurinol-base Topical Agent for Prevention of Capecitabine-induced Hand-foot Syndrome

Resource links provided by NLM:

Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Primary Outcome Measures:
  • Changes in the signs of hand-foot syndrome [ Time Frame: At 1-2-3-4-5-6 months ]
    Erythema, descamation, vesiculation

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

Enrollment: 60
Study Start Date: July 2011
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Allopurinol 3% cream
Allopurinol 3% cream in one side of the body
Drug: Allopurinol
Allopurinol 3% cream application in one side of the body, twice a day for 6 months
Placebo Comparator: Placebo cream
Placebo cream in the other side of the body
Drug: Placebo
Placebo cream application in the other side of the body, twice a day for 6 months


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01609166

Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  More Information

Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Identifier: NCT01609166     History of Changes
Other Study ID Numbers: IIB-ALO-2010-02
2010-022095-31 ( EudraCT Number )
Study First Received: May 24, 2012
Last Updated: May 22, 2014

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Hand-foot Syndrome

Additional relevant MeSH terms:
Hand-Foot Syndrome
Pathologic Processes
Drug Eruptions
Skin Diseases
Drug Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Protective Agents
Physiological Effects of Drugs processed this record on April 26, 2017