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

NCT00746694CompletedOBSERVATIONAL

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.

Key Facts

Lead Sponsor

Merck Sharp & Dohme LLC

Enrollment

154

Start Date

2007-10-01

Completion Date

2009-06-01

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

Conditions

Ovarian NeoplasmsBreast NeoplasmsParesthesia

Eligibility

Age Range

18 Years+

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

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.

Time frame: Participants will do a single visit, but cases will be collected during a period of 12 months.

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.

Time frame: Participants will do a single visit, but cases will be collected during a period of 12 months.

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.

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