Status:
TERMINATED
Evaluation of Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced
Lead Sponsor:
Institut Claudius Regaud
Conditions:
Neoplasms
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the response rate obtained in an heterogeneous oncologic population treated by chemotherapy, and either by Darbepoetin alfa classic treatment or by association...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Well-informed written consent, signed by the patient
- Patient picked up for solid tumor treatment, whichever the localization, with or without metastasis
- Patient revealing, before or during chemotherapy, a moderate anemia, that means: Men: 9\<Hb\<12 g/dl; Women: 9\<Hb\<11 g/dl.
- Patient for who at least four chemotherapy cycles are planed (eight in case of weekly chemotherapy) after inclusion in the study
- Patients with life expectancy higher than three months
- Patient with general conditions compatible with the study's follow-up
Exclusion
- Contra-indication for Venofer
- Anemia which can have curative treatment
- Bloody transfusion during the previous four weeks
- Documented or suspected medullary invasion
- Uncontrolled arterial hypertension
- Acute bacterial infection
- Transferrin saturation's coefficient
- Pregnancy
- Ferric salts oral treatment interrupted since less than one week
- Patient with bad french language's comprehension
- Patient with a major psychiatric pathology
- Patient under guardianship, trusteeship or justice safeguard
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00210002
Start Date
November 1 2003
End Date
April 1 2006
Last Update
November 14 2006
Active Locations (4)
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1
Centre Hospitalier de Castres
Castres, France
2
Centre Hospitalier de Montauban
Montauban, France
3
Centre Hospitalier Joseph Ducuing
Toulouse, France
4
Institut Claudius Regaud
Toulouse, France