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

ISRCTN ISRCTN11830961
DOI https://doi.org/10.1186/ISRCTN11830961
ClinicalTrials.gov number NCT00482716
Secondary identifying numbers Version 2 (Oct 2006)
Submission date
17/11/2006
Registration date
04/05/2007
Last edited
07/08/2009
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Samir Agrawal
Scientific

Barts and the London NHS Trust
St Bartholomew’s Hospital
West Smithfield
London
EC1A 7BE
United Kingdom

Phone +44 (0)20 7601 2331
Email s.g.agrawal@qmul.ac.uk

Study information

Study designRandomised, controlled, open label, prospective trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymHigh Iron Study
Study objectivesParental iron will optimise the response to recombinant erythropoietin therapy in patients who are iron replete.
Ethics approval(s)Approval received from the East London and the City Research Ethics Committee on the 17th October 2006 (ref: 06/Q0605/93).
Health condition(s) or problem(s) studiedChemotherapy induced anaemia
InterventionAs 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)
Intervention typeSupplement
Primary outcome measureThe primary outcome will be the maximum haemoglobin achieved during the conduct of the study.
Secondary outcome measuresThe 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.
Overall study start date01/11/2006
Completion date24/04/2009
Reason abandoned (if study stopped)Participant recruitment issue

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsEighty patients
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/11/2006
Date of final enrolment24/04/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Barts and the London NHS Trust
London
EC1A 7BE
United Kingdom

Sponsor information

Barts and the London NHS Trust (UK)
Hospital/treatment centre

Research and Development Department
3rd Floor Rutland House
42-46 New Road
Whitechapel
London
E1 2AX
England
United Kingdom

Phone +44 (0)20 7882 7260
Email Gerry.Leonard@bartsandthelondon.nhs.uk
Website http://www.bartsandthelondon.org.uk/
ROR logo "ROR" https://ror.org/00b31g692

Funders

Funder type

Hospital/treatment centre

St. Bartholomew's Hospital (UK) - internal funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan