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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Anemia, Fatigue, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Biological: epoetin beta
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: epoetin beta|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue |  |  | 
| Quality of life |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin level |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific, anemia, fatigue