N/A
N=154
A Study to Determine the Management of Palmar-plantar Erythrodysesthesia (PPE) in Patients With Metastatic Ovarian or Breast Cancer Treated With Caelyx (Study P05020)
Ovarian Neoplasms · Breast Neoplasms · Paresthesia
Bottom Line
View on ClinicalTrials.gov: NCT00746694 ↗Enrolled (actual)
154
Serious AEs
2.0%
Results posted
Jan 2011
Primary outcome: Primary: Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE) — 10; 8; 8; 3 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE) |
10; 8; 8; 3; 1; 1 | — |
| PRIMARY Number of Participants That Received Curative Treatment and/or Prophylaxis Treatment for PPE |
14; 52; 6 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00746694). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.