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.
Sponsor:
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT00180999
First received: September 13, 2005
Last updated: September 7, 2006
Last verified: September 2006
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

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
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Principal Investigator: Valérie LAPIERRE, MD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00180999     History of Changes
Other Study ID Numbers: TUMFATIGUE, CSET 98/663
Study First Received: September 13, 2005
Last Updated: September 7, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on April 15, 2014