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

Breast Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00746694
• Other study ID #: P05020
• Status: Completed
• Phase: N/A
• First received: September 3, 2008
• Last updated: August 26, 2015
• Start date: October 2007
• Est. completion date: June 2009

Study information

• Verified date: August 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Breast Neoplasms
• Hand-Foot Syndrome
• Neoplasms
• Ovarian Neoplasms
• Paresthesia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE)	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.	Participants will do a single visit, but cases will be collected during a period of 12 months.	Yes
Primary	Number of Participants That Received Curative Treatment and/or Prophylaxis Treatment for PPE	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.	Participants will do a single visit, but cases will be collected during a period of 12 months.	Yes