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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00746694
Recruitment Status : Completed
First Posted : September 4, 2008
Results First Posted : January 17, 2011
Last Update Posted : August 27, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease
Ovarian Neoplasms Breast Neoplasms Paresthesia

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Study Type : Observational
Actual Enrollment : 154 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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
Study Start Date : October 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment and according to data sheet approved indications.

Primary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with metastatic ovarian or breast cancer, to be recruited from the Oncology Departments of 16 centers for a period of 12 months.

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.

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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00746694    
Other Study ID Numbers: P05020
First Posted: September 4, 2008    Key Record Dates
Results First Posted: January 17, 2011
Last Update Posted: August 27, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Breast Neoplasms
Ovarian Neoplasms
Hand-Foot Syndrome
Neoplasms by Site
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Drug Eruptions
Drug Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms