A Study to Determine the Management of Palmar-plantar Erythrodysesthesia (PPE) in Patients With Metastatic Ovarian or Breast Cancer Treated With Caelyx (Study P05020)
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||Epidemiological Study to Assess the Management of Palmar-plantar Erythrodysesthesia (PPE) in Patients With Metastatic Ovarian or Breast Cancer Treated With Pegylated Liposomal Doxorubicin|
- Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE) [ Time Frame: Participants will do a single visit, but cases will be collected during a period of 12 months. ] [ Designated as safety issue: Yes ]
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 [ Time Frame: Participants will do a single visit, but cases will be collected during a period of 12 months. ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||October 2007|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment and according to data sheet approved indications.
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