Randomised Study to Compare the Effect of r-Hu-EPO Administration With Transfusion of Red Blood Cell Concentrates and Also With the Administration of Polyvitamins in Anemic and Tired Patients Presenting a Bad Prognostic in Middle Course

This study has been terminated.

Sponsored by:	Institut Gustave Roussy
Information provided by:	Institut Gustave Roussy
ClinicalTrials.gov Identifier:	NCT00180999

Purpose

Randomised study to compare the effect of r-Hu-EPO administration with transfusion of Red Blood cell concentrates and also with the administration of polyvitamins in anemic and tired patients presenting a bad prognostic in middle course.

Condition	Intervention	Phase
- Medico-Economic Aspects (Evaluation of Medical Costs Related to the Three Strategies and Evaluation of Cost/Efficacy)	Drug: Erythropoiétine	Phase III

MedlinePlus related topics: Blood Transfusion and Donation

Drug Information available for: Erythropoietin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Randomised Study to Compare the Effect of r-Hu-EPO Administration With Transfusion of Red Blood Cell Concentrates and Also With the Administration of Polyvitamins in Anemic and Tired Patients Presenting a Bad Prognostic in Middle Course

Further study details as provided by Institut Gustave Roussy:

Primary Outcome Measures:

Quality of life, in particular when related to tiredness (FACT F)

Estimated Enrollment:	420
Study Start Date:	February 2002

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Both sexes
18-70 yrs
metastatic or locally advanced cancer
Life expectancy > 3 months
hemoglobin between 7 and 10 g/100ml
no contraindication to r-Hu-EPO
with written informed consent at entry time

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180999

Locations

France
Institut Gustave-Roussy
Villejuif, France, 94800

Sponsors and Collaborators

Institut Gustave Roussy

Investigators

Principal Investigator:

Valérie LAPIERRE, MD

Institut Gustave Roussy

More Information

Study ID Numbers:	TUMFATIGUE, CSET 98/663
Study First Received:	September 13, 2005
Last Updated:	September 7, 2006
ClinicalTrials.gov Identifier:	NCT00180999
Health Authority:	France: Afssaps - French Health Products Safety Agency

ClinicalTrials.gov processed this record on January 16, 2009