Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2026-04-08 @ 3:27 PM
Study NCT ID:
NCT00559195
Status:
COMPLETED
Last Update Posted:
2011-05-16
First Post:
2007-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epoetin Beta in Treating Fatigue and Anemia in Patients Receiving Palliative Care for Malignant Solid Tumors
Sponsor:
Centre Hospital Regional Universitaire de Limoges
Organization:
Study Overview
Official Title:
Phase 2 Study Evaluating the Efficacy of Epoetin Beta (Neocormon®) For Fatigue and Quality of Life of Patients Receiving Palliative Care for a Solid Malignant Tumor
Status:
COMPLETED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: