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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00559195

Enrollment

Registered

2007-11-16

Start date

2005-11-30

Completion date

Unknown

Last updated

2011-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Fatigue, Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific, anemia, fatigue

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.

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.

Interventions

BIOLOGICALepoetin beta

PROCEDUREquality-of-life assessment

Study design

Allocation

NON_RANDOMIZED

Primary purpose

SUPPORTIVE_CARE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Fatigue	—
Quality of life	—

Secondary

Measure	Time frame
Hemoglobin level	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026