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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
First received: September 3, 2008
Last updated: August 26, 2015
Last verified: August 2015
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.
||Observational Model: Case-Only
Time Perspective: Cross-Sectional
||Epidemiological Study to Assess the Management of Palmar-plantar Erythrodysesthesia (PPE) in Patients With Metastatic Ovarian or Breast Cancer Treated With Pegylated Liposomal Doxorubicin
Primary Outcome Measures:
- 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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2009 (Final data collection date for primary outcome measure)
Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment and according to data sheet approved indications.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Participants with metastatic ovarian or breast cancer, to be recruited from the Oncology Departments of 16 centers for a period of 12 months.
- 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.
- Participants who are currently participating in a clinical trial.
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No Contacts or Locations Provided
||Merck Sharp & Dohme Corp.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 3, 2008
|Results First Received:
||December 21, 2010
||August 26, 2015
||Spain: Spanish Agency of Medicines
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 02, 2016
Drug-Related Side Effects and Adverse Reactions
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms by Site
Nervous System Diseases
Signs and Symptoms