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临床试验/NCT01291628
NCT01291628Unknown不适用

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

Rabin Medical Center2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
10
试验地点
2
主要终点
skin feet toxicity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of stage IV cancer - treated with Capecitabine

排除标准

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

结局指标

主要结局

skin feet toxicity

时间窗: 1 year

within the first year from starting Capecitabine use

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

rinat yerushalmi

Medical Oncologist

Rabin Medical Center

研究点 (2)

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