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

Primary Purpose

Anemia, Fatigue, Unspecified Adult Solid Tumor, Protocol Specific

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
epoetin beta
quality-of-life assessment
Sponsored by
Centre Hospital Regional Universitaire de Limoges
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anemia focused on measuring unspecified adult solid tumor, protocol specific, anemia, fatigue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospital Regional Universitaire de Limoges

Outcomes

Primary Outcome Measures

Fatigue
Quality of life

Secondary Outcome Measures

Hemoglobin level

Full Information

First Posted
November 15, 2007
Last Updated
May 13, 2011
Sponsor
Centre Hospital Regional Universitaire de Limoges
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1. Study Identification

Unique Protocol Identification Number
NCT00559195
Brief Title
Epoetin Beta in Treating Fatigue and Anemia in Patients Receiving Palliative Care for Malignant Solid Tumors
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Centre Hospital Regional Universitaire de Limoges

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Fatigue, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
unspecified adult solid tumor, protocol specific, anemia, fatigue

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
epoetin beta
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
Fatigue
Title
Quality of life
Secondary Outcome Measure Information:
Title
Hemoglobin level

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Luc Labourey
Organizational Affiliation
Centre Hospital Regional Universitaire de Limoges
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Hospital Regional Universitaire de Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France

12. IPD Sharing Statement

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

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