- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00559195
Epoetin Beta in Treating Fatigue and Anemia in Patients Receiving Palliative Care for Malignant Solid Tumors
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
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Limoges, France, 87042
- Centre Hospital Regional Universitaire de Limoges
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically confirmed malignant solid tumor
- No hematologic malignancy
- Hemoglobin < 10.5 g/dL (anemic)
- Receiving palliative care only
PATIENT CHARACTERISTICS:
- Life expectancy > 6 months
- Negative pregnancy test
- Fertile patients must use effective contraception
- No chronic anemia requiring treatment (e.g., thalassemia or sickle cell disease)
- No uncontrolled hypertension
- No allergy to any drugs or components used in the study
- Not a prisoner or under guardianship or trusteeship
- No mental disability that impairs a clear understanding of the study requirements
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 2 months since prior specific anticancer therapy (e.g., chemotherapy, hormonal therapy, targeted therapy, or immunotherapy)
- More than 1 month since prior and no concurrent participation in another clinical trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Quality of life
|
Fatigue
|
Secondary Outcome Measures
Outcome Measure |
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Hemoglobin level
|
Collaborators and Investigators
Investigators
- Study Chair: Jean-Luc Labourey, Centre Hospital Regional Universitaire de Limoges
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000574173
- CHUL-NEOPALIA
- RECF0359
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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