Clinical trial · Observational
A Study to Determine the Management of Palmar-plantar Erythrodysesthesia (PPE) in Patients With Metastatic Ovarian or Breast Cancer Treated With Caelyx (Study P05020)
Epidemiological Study to Assess the Management of Palmar-plantar Erythrodysesthesia (PPE) in Patients With Metastatic Ovarian or Breast Cancer Treated With Pegylated Liposomal Doxorubicin
NCT00746694CI-TRIAL-00018952completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Paresthesia | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Caelyx
- description
- Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment and according to data sheet approved indications.
Primary outcomes (2)
- measure
- Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE)
- timeFrame
- Participants will do a single visit, but cases will be collected during a period of 12 months.
- description
- 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.
- measure
- Number of Participants That Received Curative Treatment and/or Prophylaxis Treatment for PPE
- timeFrame
- Participants will do a single visit, but cases will be collected during a period of 12 months.
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.