Anemia Clinical Trial
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
Verified date | May 2011 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
France | Centre Hospital Regional Universitaire de Limoges | Limoges |
Lead Sponsor | Collaborator |
---|---|
Centre Hospital Regional Universitaire de Limoges |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fatigue | |||
Primary | Quality of life | |||
Secondary | Hemoglobin level |
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