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

Hand-foot Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01609166
• Other study ID #: IIB-ALO-2010-02
• Secondary ID: 2010-022095-31
• Status: Completed
• Phase: Phase 2
• First received: May 24, 2012
• Last updated: May 22, 2014
• Start date: July 2011
• Est. completion date: December 2012

Study information

• Verified date: May 2014
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hand-foot Syndrome
• Syndrome

Intervention

Drug:
• Allopurinol
Allopurinol 3% cream application in one side of the body, twice a day for 6 months
• Placebo
Placebo cream application in the other side of the body, twice a day for 6 months

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the signs of hand-foot syndrome	Erythema, descamation, vesiculation	At 1-2-3-4-5-6 months	No
Secondary	Changes in the symptoms of hand-foot syndrome	Burning, prurigo	At 1-2-3-4-5-6 months	No