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

NCT00746694 | Completed Results

• 1 other identifier: P05020
• Study Type: observational
• Target: 154
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ovarian Neoplasms; Breast Neoplasms; Paresthesia

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE)

  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.

  Participants will do a single visit, but cases will be collected during a period of 12 months.

• Number of Participants That Received Curative Treatment and/or Prophylaxis Treatment for PPE

  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.

  Participants will do a single visit, but cases will be collected during a period of 12 months.

Study Arms (1)

Caelyx

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Participants who are currently participating in a clinical trial.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Ovarian Neoplasms; Breast Neoplasms; Paresthesia

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2008
• First Posted: September 4, 2008
• Study Start: October 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: August 27, 2015
• Results First Posted: January 17, 2011

Record last verified: 2015-08