ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01609166
Recruitment Status : Completed
First Posted : May 31, 2012
Last Update Posted : May 23, 2014
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Hand-foot Syndrome Drug: Allopurinol Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (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
Study Start Date : July 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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



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


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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01609166


Locations
Spain
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

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 ( EudraCT Number )
First Posted: May 31, 2012    Key Record Dates
Last Update Posted: May 23, 2014
Last Verified: May 2014

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:
Syndrome
Hand-Foot Syndrome
Disease
Pathologic Processes
Drug Eruptions
Dermatitis
Skin Diseases
Drug Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Capecitabine
Allopurinol
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs