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

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: November 15, 2007
Last updated: May 13, 2011
Last verified: May 2011

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.

Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Biological: epoetin beta
Procedure: quality-of-life assessment
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Supportive Care
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

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Fatigue
  • Quality of life

Secondary Outcome Measures:
  • Hemoglobin level

Estimated Enrollment: 40
Study Start Date: November 2005
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Detailed Description:



  • Evaluate the impact of epoetin beta on fatigue and quality of life of patients receiving palliative care for malignant solid tumors.


  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed malignant solid tumor

    • No hematologic malignancy
  • Hemoglobin < 10.5 g/dL (anemic)
  • Receiving palliative care only


  • 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


  • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00559195

Centre Hospital Regional Universitaire de Limoges
Limoges, France, 87042
Sponsors and Collaborators
Centre Hospital Regional Universitaire de Limoges
Study Chair: Jean-Luc Labourey Centre Hospital Regional Universitaire de Limoges
  More Information Identifier: NCT00559195     History of Changes
Other Study ID Numbers: CDR0000574173
Study First Received: November 15, 2007
Last Updated: May 13, 2011

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Hematologic Diseases
Signs and Symptoms
Epoetin Alfa
Hematinics processed this record on May 25, 2017