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

NCT ID: NCT00746694

Last Updated: 2015-08-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

154 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Ovarian Neoplasms Breast Neoplasms Paresthesia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Caelyx

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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P05020

Identifier Type: -

Identifier Source: org_study_id

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