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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00559195
First received: November 15, 2007
Last updated: May 13, 2011
Last verified: May 2011
  Purpose

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
Anemia
Fatigue
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:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00559195

Locations
France
Centre Hospital Regional Universitaire de Limoges
Limoges, France, 87042
Sponsors and Collaborators
Centre Hospital Regional Universitaire de Limoges
Investigators
Study Chair: Jean-Luc Labourey Centre Hospital Regional Universitaire de Limoges
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00559195     History of Changes
Other Study ID Numbers: CDR0000574173, CHUL-NEOPALIA, RECF0359
Study First Received: November 15, 2007
Last Updated: May 13, 2011
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Anemia
Fatigue
Neoplasms
Hematologic Diseases
Signs and Symptoms
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014