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


Phase 2
18 Years
N/A
Not Enrolling
Both
Neoplasms, Anemia

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Biological response rate for each group.

Principal Investigator

Roland Dugat, Pr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Claudius Regaud

Authority:

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

Study ID:

03 DIVE 01

NCT ID:

NCT00210002

Start Date:

November 2003

Completion Date:

April 2006

Related Keywords:

  • Neoplasms
  • Anemia
  • Neoplasms
  • Solid
  • Anemia
  • darbepoetin alfa
  • ferric saccharose
  • Venofer®
  • Aranesp®
  • Anemia
  • Neoplasms

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