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Clinical Trials/NCT01291628
NCT01291628UnknownNot Applicable

A Pilot Study- Prevention of Capecitabine Induced Hand and Foot Syndrome

Rabin Medical Center2 sites in 1 country10 target enrollmentStarted: January 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
10
Locations
2
Primary Endpoint
skin feet toxicity

Study Overview

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Clinical diagnosis of stage IV cancer - treated with Capecitabine

Exclusion Criteria

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

Outcomes

Primary Outcomes

skin feet toxicity

Time Frame: 1 year

within the first year from starting Capecitabine use

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

rinat yerushalmi

Medical Oncologist

Rabin Medical Center

Study Sites (2)

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