Evaluation of Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced
NCT ID: NCT00210002
Last Updated: 2006-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
55 participants
INTERVENTIONAL
2003-11-30
2006-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Interventions
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Darbepoetin alfa (Aranesp®)
Ferric saccharose(Venofer®)
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Institut Claudius Regaud
OTHER
Principal Investigators
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Roland Dugat, Pr
Role: PRINCIPAL_INVESTIGATOR
Institut Claudius Regaud
Locations
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Centre Hospitalier de Castres
Castres, , France
Centre Hospitalier de Montauban
Montauban, , France
Centre Hospitalier Joseph Ducuing
Toulouse, , France
Institut Claudius Regaud
Toulouse, , France
Countries
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Other Identifiers
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03 DIVE 01
Identifier Type: -
Identifier Source: org_study_id