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

NCT ID: NCT00559195

Last Updated: 2011-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Brief Summary

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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

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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.

Conditions

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Anemia Fatigue Unspecified Adult Solid Tumor, Protocol Specific

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

SUPPORTIVE_CARE

Interventions

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epoetin beta

Intervention Type BIOLOGICAL

quality-of-life assessment

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospital Regional Universitaire de Limoges

OTHER

Sponsor Role lead

Principal Investigators

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Jean-Luc Labourey

Role: STUDY_CHAIR

Centre Hospital Regional Universitaire de Limoges

Locations

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Centre Hospital Regional Universitaire de Limoges

Limoges, , France

Site Status

Countries

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France

Other Identifiers

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CHUL-NEOPALIA

Identifier Type: -

Identifier Source: secondary_id

RECF0359

Identifier Type: -

Identifier Source: secondary_id

CDR0000574173

Identifier Type: -

Identifier Source: org_study_id

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