Randomised controlled study of iron supplementation to support the response to recombinant human erythropoietin for the treatment of chemotherapy-induced anaemia

Completed

Conditions: Chemotherapy induced anaemia
Haematological Disorders
Anaemia in chronic diseases classified elsewhere

Registration Number: ISRCTN11830961

Lead Sponsor: Barts and the London NHS Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

1. Any patients with a haemoglobin of less than or equal to 10.5 g/dl who is going to receive at least six more weeks of chemotherapy for any non-myeloid malignancy
2. Any patients with a percent saturation of transferrin more than or equal to 20% and a serum ferritin between 225 and 2250 pmol/L. Confirmatory data will include a reticulocyte haemoglobin content (CHR) more than 31 and zinc protoporphyrin (ZPP) less than 80
3. Patients must be able to understand and signed written informed consent
4. An Eastern Cooperative Oncology Group (ECOG) performance status of zero to two

Exclusion Criteria

1. Patients with an anaemia of origin other than cancer or cancer chemotherapy
2. Prior intravenous (IV) iron therapy
3. Expectation of actual transfusion requirement during the course of the study. A transfusion given after randomisation wil be a study endpoint for that patient.
4. Allergy or intolerance to recombinant erythropoietin
5. Uncontrolled hypertension
6. Active infection
7. Primary bone marrow malignancies except for multiple myeloma, chronic lymphocytic leukaemia and indolent non Hogkin's lymphoma, where erythropoiesis-stimulating agents (ESA) therapy has been proven to be beneficial

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be the maximum haemoglobin achieved during the conduct of the study.

Secondary Outcome Measures

Name	Time	Method
The secondary outcome will be the time to zenith haemoglobin or the achievement of a haemoglobin level of more than 13 g. All side effects will be recorded and graded although none are anticipated. A further stratification will be responsive, stable or progressive disease.