Prevention of Capecitabine Induced Hand and Foot Syndrome

Not Applicable

• Conditions: Cancer
• Interventions: Device: socks containing copper-oxide fibers

• Registration Number: NCT01291628
• Lead Sponsor: Rabin Medical Center

Brief Summary

Capecitabine is a common anti cancer drug. One of the most common side effects is a syndrome called hand and foot syndrome which comprises of hands and feet redness, swelling, dryness and painful sores. Quite often the drug dose is reduced to suboptimal level due to this side effect. There is no way to prevent or an effective way to treat this side effect. The investigators aim is to investigate whether wearing socks which contain copper fibers may prevent or alleviate the patient symptoms.

Detailed Description

Capecitabine is a common anti cancer drug. One of the most common side effects is a syndrome called hand and foot syndrome which comprises of hands and feet redness, swelling, dryness and painful sores. Quite often the drug dose is reduced to suboptimal level due to this side effect. There is no way to prevent or an effective way to treat this side effect. Our aim is to investigate whether wearing socks which contain copper fibers may prevent or alleviate the patient symptoms.

The patients will use socks containing copper-oxide impregnated fibers which are sold in the Pharma stores without physician's prescription.(EPA numbers 8454-2, 8454-3 from April 30 2009).

Drug Toxicity and skin reaction will be documented.

Study Timeline

• Study First Submitted: 2011-02-07
• Study First Submitted QC: 2011-02-07
• Study First Posted: 2011-02-08
• Status Verified: 2012-01
• Study Start: 2012-01
• Last Update Submitted: 2012-01-18
• Last Update Posted: 2012-01-19
• Primary Completion: 2014-01
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Clinical diagnosis of stage IV cancer - treated with Capecitabine

Exclusion Criteria

• Any patient who can not sign an informed consent
• Pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
socks containing copper-oxide fibers	socks containing copper-oxide fibers	-

Primary Outcome Measures

Name	Time	Method
skin feet toxicity	1 year	within the first year from starting Capecitabine use

Trial Locations

Locations (1)

Rabin Medical Center, Oncology department; 🇮🇱 Petach-Tikva, Israel