A Study to Determine the Management of Palmar-plantar Erythrodysesthesia (PPE) in Patients With Metastatic Ovarian or Breast Cancer Treated With Caelyx (Study P05020)
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|ClinicalTrials.gov Identifier: NCT00746694|
Recruitment Status : Completed
First Posted : September 4, 2008
Results First Posted : January 17, 2011
Last Update Posted : August 27, 2015
|Condition or disease|
|Ovarian Neoplasms Breast Neoplasms Paresthesia|
|Study Type :||Observational|
|Actual Enrollment :||154 participants|
|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|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
U.S. FDA Resources
Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment and according to data sheet approved indications.
- 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. ]
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. ]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.