- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Barcelona, Spain, 08025
- Hospital de la Santa Creu i Sant Pau
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Allopurinol 3% cream
Allopurinol 3% cream in one side of the body
|
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
|
Placebo cream application in the other side of the body, twice a day for 6 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in the signs of hand-foot syndrome
Time Frame: At 1-2-3-4-5-6 months
|
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
Time Frame: At 1-2-3-4-5-6 months
|
Burning, prurigo
|
At 1-2-3-4-5-6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Pathologic Processes
- Skin Diseases
- Disease
- Dermatitis
- Drug-Related Side Effects and Adverse Reactions
- Drug Eruptions
- Drug Hypersensitivity
- Syndrome
- Hand-Foot Syndrome
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites
- Protective Agents
- Antioxidants
- Free Radical Scavengers
- Gout Suppressants
- Allopurinol
Other Study ID Numbers
- IIB-ALO-2010-02
- 2010-022095-31 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hand-foot Syndrome
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Universitas SriwijayaActive, not recruitingCapecitabine | Hand and Foot Syndrome | Hand and Foot Skin ReactionIndonesia
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China-Japan Friendship HospitalCompleted
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Jessa HospitalHasselt UniversityRecruitingHand-foot Syndrome | Hand-foot Skin ReactionBelgium
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Quanta MedicalNAOS Institute of Life ScienceCompletedGrade 2 Hand-foot SyndromFrance
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Northwestern UniversityCompletedHand Foot Skin ReactionUnited States
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China Medical University HospitalNot yet recruiting
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruitingHand-foot SyndromeChina
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Instituto Brasileiro de Controle do CancerWecare Comércio de CosméticosRecruiting
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Nan xuCompleted
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Heinrich-Heine University, DuesseldorfTerminatedThe Effect of Topical Brimonidine Tartrate on Hand-foot Syndrome (HFS) in Cancer Patients (BRIMOCAN)Hand-foot SyndromeGermany
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University of DundeeCompleted
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Ardea Biosciences, Inc.Completed
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