Epoetin Beta in Treating Fatigue and Anemia in Patients Receiving Palliative Care for Malignant Solid Tumors

Phase 2

Completed

• Conditions: Anemia; Fatigue; Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00559195
• Lead Sponsor: Centre Hospital Regional Universitaire de Limoges

Brief Summary

RATIONALE: Epoetin beta may cause the body to make more red blood cells and may help relieve fatigue in patients with malignant solid tumors receiving palliative care.

PURPOSE: This phase II trial is studying how well epoetin beta works in treating fatigue and anemia in patients receiving palliative care for malignant solid tumors.

Detailed Description

OBJECTIVES:

Primary

* Evaluate the impact of epoetin beta on fatigue and quality of life of patients receiving palliative care for malignant solid tumors.

Secondary

* Evaluate the impact of epoetin beta on hemoglobin level (increase \> 2 g/dL).

OUTLINE: Patients receive epoetin beta subcutaneously once a week for up to 3 months.

Fatigue, quality of life, and hemoglobin and reticulocyte levels are assessed every 4 weeks.

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2007-11-15
• Study First Submitted QC: 2007-11-15
• Study First Posted: 2007-11-16
• Status Verified: 2011-05
• Primary Completion: 2011-05
• Last Update Submitted: 2011-05-13
• Last Update Posted: 2011-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fatigue
Quality of life

Secondary Outcome Measures

Name	Time	Method
Hemoglobin level

Trial Locations

Locations (1)

Centre Hospital Regional Universitaire de Limoges; 🇫🇷 Limoges, France