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ISRCTN
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ISRCTN11830961
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ClinicalTrials.gov identifier
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NCT00482716
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Public title
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Randomised controlled study of iron supplementation to support the response to recombinant human erythropoietin for the treatment of chemotherapy-induced anaemia
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Scientific title
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Acronym
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High Iron Study
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Serial number at source
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Version 2 (Oct 2006)
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Study hypothesis
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Parental iron will optimise the response to recombinant erythropoietin therapy in patients who are iron replete.
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Ethics approval
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Approval received from the East London and the City Research Ethics Committee on the 17th October 2006 (ref: 06/Q0605/93).
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Study design
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Randomised, controlled, open label, prospective trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Chemotherapy induced anaemia
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/11/2006
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Anticipated end date
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24/04/2009
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Status of trial
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Stopped |
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Patient information material
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Target number of participants
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Eighty patients
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Interventions
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As of 07/08/2009 the status of this record was updated to read: 'STOPPED', as this trial terminated early due to poor patient recruitment. The initial anticipated end date was 01/11/2007 but this was extended after the lack of recruitment.
Eighty patients will be treated and randomised to receive either epoietin or epoietin plus 200 mg intravenous iron sucrose (Venefor) weekly for ten weeks or until a haemoglobin (Hb) of 13 g/dl is achieved (whichever is first). Any patient requiring blood transfusion while on the study will be considered to have completed the study at the time of the transfusion. Patients will be followed until the Hb reaches 13 g or until the end of the study period. Haemoglobin levels will be measured weekly.
Other blood tests include:
Baseline: zinc protoporphyrin (ZPP), reticulocyte haemoglobin content (CHR), transferrin saturation (TSAT), full blood count (FBC), ferritin, reticulocytes (Retic), vitamin B12, red cell folate, soluble transferrin receptor (sTFR), serum erythropoietin (EPO)
Week one: FBC, CHR, retic
Week four, eight and 12: as per baseline (without B12 and red cell folate)
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Primary outcome measure(s)
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The primary outcome will be the maximum haemoglobin achieved during the conduct of the study.
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Secondary outcome measure(s)
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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.
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Sources of funding
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St. Bartholomew's Hospital (UK) - internal funding
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Trial website
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Publications
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Contact name
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Dr
Samir
Agrawal
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Address
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Barts and the London NHS Trust
St Bartholomew’s Hospital
West Smithfield
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City/town
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London
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Zip/Postcode
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EC1A 7BE
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Country
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United Kingdom
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Tel
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+44 (0)20 7601 2331
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Fax
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+44 (0)20 7601 8200
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Email
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s.g.agrawal@qmul.ac.uk
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Sponsor
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Barts and the London NHS Trust (UK)
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Address
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Research and Development Department
3rd Floor Rutland House
42-46 New Road
Whitechapel
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City/town
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London
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Zip/Postcode
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E1 2AX
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Country
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United Kingdom
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Tel
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+44 (0)20 7882 7260
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Fax
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+44 (0)20 7882 7276
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Email
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Gerry.Leonard@bartsandthelondon.nhs.uk
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Sponsor website:
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http://www.bartsandthelondon.org.uk/
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Date applied
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17/11/2006
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Last edited
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07/08/2009
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Date ISRCTN assigned
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04/05/2007
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