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

Completed

• Conditions: Breast Neoplasms; Ovarian Neoplasms; Paresthesia

• Registration Number: NCT00746694
• Lead Sponsor: Merck Sharp & Dohme LLC

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 Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-09-03
• Study First Submitted QC: 2008-09-03
• Study First Posted: 2008-09-04
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Results First Submitted: 2010-12-21
• Results First Submitted QC: 2010-12-21
• Results First Posted: 2011-01-17
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-26
• Last Update Posted: 2015-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 154

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.

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Exclusion Criteria

• Participants who are currently participating in a clinical trial.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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