NCT00559195

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2007

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Last Updated

May 16, 2011

Status Verified

May 1, 2011

Enrollment Period

5.5 years

First QC Date

November 15, 2007

Last Update Submit

May 13, 2011

Conditions

AnemiaFatigueUnspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specificanemiafatigue

Outcome Measures

Primary Outcomes (2)

  • Fatigue

  • Quality of life

Secondary Outcomes (1)

  • Hemoglobin level

Interventions

epoetin betaBIOLOGICAL
quality-of-life assessmentPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Centre Hospital Regional Universitaire de Limoges

Limoges, 87042, France

Location

MeSH Terms

Conditions

AnemiaFatigue

Interventions

epoetin beta

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jean-Luc Labourey

    Centre Hospital Regional Universitaire de Limoges

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 15, 2007

First Posted

November 16, 2007

Study Start

November 1, 2005

Primary Completion

May 1, 2011

Last Updated

May 16, 2011

Record last verified: 2011-05

Locations

FR(1)