Evaluation of Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced

Study Overview
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Brief Summary
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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 of Darbepoetin alfa -ferric saccharose systematic supplementation, administered concomitantly with chemotherapy.

Official Title
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Evaluation of Systematic Intravenous Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced.

Conditions
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Neoplasms, Anemia

Intervention / Treatment
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* Drug: Darbepoetin alfa (Aranesp®)
* Drug: Ferric saccharose(Venofer®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Darbepoetin alfa (Aranesp®)|nan|
|Drug: Ferric saccharose(Venofer®)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biological response rate for each group. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine tolerance for ferric saccharose (Venofer®) |  |  | 
| To determine percentage of patients who necessitate an increase of Darbepoetin alfa's dose(Aranesp®) |  |  | 
| To determine percentage of hemoglobin rate's correction |  |  | 
| To determine biological parameters's evolution |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Solid, Neoplasms, Anemia, darbepoetin alfa, ferric saccharose, Venofer®, Aranesp®