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临床试验/NCT00746694
NCT00746694已完成不适用

Epidemiological Study to Assess the Management of Palmar-plantar Erythrodysesthesia (PPE) in Patients With Metastatic Ovarian or Breast Cancer Treated With Pegylated Liposomal Doxorubicin

Merck Sharp & Dohme LLC0 个研究点目标入组 154 人开始时间: 2007年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
154
主要终点
Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE)

研究概览

简要总结

The objective of this trial is to study the management of PPE in participants with metastatic ovarian or breast cancer treated with Caelyx, and determine the frequency of use of pharmacological treatment (preventive or therapeutic) for PPE and compliance of educational recommendations for PPE.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

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

入选标准

  • Women 18 years of age or older.
  • Participants with metastatic breast or ovarian cancer who are receiving treatment with pegylated liposomal doxorubicin.
  • Participants who have given their written consent.

排除标准

  • Participants who are currently participating in a clinical trial.

结局指标

主要结局

Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE)

时间窗: Participants will do a single visit, but cases will be collected during a period of 12 months.

Participants treated with Caelyx who developed PPE and the categories of specific treatment strategies that were prescribed to manage the symptoms of PPE. Participants counted under the strategies: Keep Skin Hydrated; Avoid Sweating and Physical Activity; Avoid Tight-Fitting Clothing; Local Cooling of Hands and Feet; were those who either always or sometimes followed it.

Number of Participants That Received Curative Treatment and/or Prophylaxis Treatment for PPE

时间窗: Participants will do a single visit, but cases will be collected during a period of 12 months.

The number of participants who were treated with Caelyx, and who received either prophylactic treatment alone, or curative treatment alone, or both prophylactic and curative treatment for PPE.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

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