Epoetin Beta in Treating Fatigue and Anemia in Patients Receiving Palliative Care for Malignant Solid Tumors
NCT ID: NCT00559195
Last Updated: 2011-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2005-11-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SUPPORTIVE_CARE
Interventions
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epoetin beta
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Centre Hospital Regional Universitaire de Limoges
OTHER
Principal Investigators
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Jean-Luc Labourey
Role: STUDY_CHAIR
Centre Hospital Regional Universitaire de Limoges
Locations
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Centre Hospital Regional Universitaire de Limoges
Limoges, , France
Countries
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Other Identifiers
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CHUL-NEOPALIA
Identifier Type: -
Identifier Source: secondary_id
RECF0359
Identifier Type: -
Identifier Source: secondary_id
CDR0000574173
Identifier Type: -
Identifier Source: org_study_id
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