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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

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ClinicalTrials.gov Identifier: NCT00180999
Recruitment Status : Terminated
First Posted : September 16, 2005
Last Update Posted : September 11, 2006
Sponsor:
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary:
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 or disease Intervention/treatment 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  (Clinical Trial)
Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2002

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Quality of life, in particular when related to tiredness (FACT F)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00180999     History of Changes
Other Study ID Numbers: TUMFATIGUE
CSET 98/663
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: September 11, 2006
Last Verified: September 2006