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

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

Status and phase: Completed; Phase 2

Conditions: Hand-foot Syndrome

Treatments: Drug: Allopurinol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01609166

IIB-ALO-2010-02

2010-022095-31 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Allopurinol 3% cream

Experimental group

Description:

Allopurinol 3% cream in one side of the body

Treatment:

Drug: Allopurinol

Placebo cream

Placebo Comparator group

Description:

Placebo cream in the other side of the body

Treatment:

Drug: Placebo