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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


Phase 3
18 Years
70 Years
Not Enrolling
Both
- Medico-Economic Aspects (Evaluation of Medical Costs Related to the Three Strategies and Evaluation of Cost/Efficacy)

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Principal Investigator

Valérie LAPIERRE, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

TUMFATIGUE

NCT ID:

NCT00180999

Start Date:

February 2002

Completion Date:

Related Keywords:

  • - Medico-Economic Aspects (Evaluation of Medical Costs Related to the Three Strategies and Evaluation of Cost/Efficacy)

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