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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00746694
First received: September 3, 2008
Last updated: August 12, 2014
Last verified: August 2014

September 3, 2008
August 12, 2014
October 2007
June 2009   (final data collection date for primary outcome measure)
  • 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.
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. ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00746694 on ClinicalTrials.gov Archive Site
Not Provided
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. ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Study to Determine the Management of Palmar-plantar Erythrodysesthesia (PPE) in Patients With Metastatic Ovarian or Breast Cancer Treated With Caelyx (Study P05020)
Epidemiological Study to Assess the Management of Palmar-plantar Erythrodysesthesia (PPE) in Patients With Metastatic Ovarian or Breast Cancer Treated With Pegylated Liposomal Doxorubicin

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

Participants with metastatic ovarian or breast cancer, to be recruited from the Oncology Departments of 16 centers for a period of 12 months.

  • Ovarian Neoplasms
  • Breast Neoplasms
  • Paresthesia
Not Provided
Caelyx
Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment and according to data sheet approved indications.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
154
June 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Participants who are currently participating in a clinical trial.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00746694
P05020
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP