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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00210002 |
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Date of registration:
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12/09/2005 |
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Primary sponsor: |
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Public title:
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Evaluation of Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced
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Scientific title:
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Evaluation of Systematic Intravenous Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced. |
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Date of first enrolment:
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November 2003 |
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Target sample size:
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55 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00210002 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Countries of recruitment
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France
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Contacts
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Name:
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Roland Dugat, Pr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institut Claudius Regaud |
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Key inclusion & exclusion 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
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anemia
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Neoplasms
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Intervention(s)
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Drug: Darbepoetin alfa (Aranesp®)
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Drug: Ferric saccharose(Venofer®)
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Primary Outcome(s)
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Biological response rate for each group.
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Secondary Outcome(s)
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To determine biological parameters's evolution
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To determine percentage of hemoglobin rate's correction
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To determine percentage of patients who necessitate an increase of Darbepoetin alfa's dose(Aranesp®)
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To determine tolerance for ferric saccharose (Venofer®)
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Secondary ID(s)
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03 DIVE 01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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