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Completed

NCT Number: NCT00559195

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

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.

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Key information

Conditions

Anemia Fatigue Hematologic Diseases Hemic and Lymphatic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Unspecified Adult Solid Tumor, Protocol Specific

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Hospital Regional Universitaire de Limoges

Limoges, 87042, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

epoetin beta

Biological

quality-of-life assessment

Procedure

Primary outcomes

  1. Fatigue

  2. Quality of life

Secondary outcomes

  1. Hemoglobin level

Sponsors and collaborators

Lead sponsor

Centre Hospital Regional Universitaire de Limoges

Other

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2011
First posted
Nov 16, 2007
Registry last updated
May 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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