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

This study is currently recruiting participants.
Verified May 2012 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT01609166
First received: May 24, 2012
Last updated: May 29, 2012
Last verified: May 2012
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Foot Health
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    Erythema, descamation, vesiculation


Secondary Outcome Measures:
  • Changes in the symptoms of hand-foot syndrome [ Time Frame: At 1-2-3-4-5-6 months ] [ Designated as safety issue: No ]
    Burning, prurigo


Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Study Completion Date: December 2012
Estimated 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01609166

Contacts
Contact: Pilar Garcia, MD 0034935537007 ext 1230 mgarciam@santpau.cat

Locations
Spain
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Pilar Garcia, MD     +34 935537007 ext 1230     mgarciam@santpau.cat    
Principal Investigator: Pilar García, MD            
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  More Information

No publications provided

Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT01609166     History of Changes
Other Study ID Numbers: IIB-ALO-2010-02, 2010-022095-31
Study First Received: May 24, 2012
Last Updated: May 29, 2012
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

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

Additional relevant MeSH terms:
Allopurinol
Capecitabine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
 Free Radical Scavengers
Antioxidants
Antimetabolites
Protective Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 18, 2013