Clinical Trial: A Study to Determine the Management of Palmar-plantar Erythrodysesthesia (PPE) in Patients With Metastatic Ovarian or Breast Cancer Treated With Caelyx (Study P05020)

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief Summary: 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.

Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome:

  • 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.


Original Primary Outcome: Measures used in hospitals to manage PPE; Number of patients that receive treatment and/or prophylaxis for PPE. [ Time Frame: Patients will do a single visit, but cases will be collected during a period of 12 months. ]

Current Secondary Outcome:

Original Secondary Outcome: Modification of anti-tumor treatment to control PPE; Degrees of severity of PPE episodes; Location of PPE; Level of patient's compliance with educational measures [ Time Frame: Patients will do a single visit, but cases will be collected during a period of 12 months. ]

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: September 3, 2008
Date Started: October 2007
Date Completion:
Last Updated: August 26, 2015
Last Verified: August 2015