Contact information
Type
Scientific
Primary contact
Dr Samir Agrawal
ORCID ID
Contact details
Barts and the London NHS Trust
St Bartholomews Hospital
West Smithfield
London
EC1A 7BE
United Kingdom
+44 (0)20 7601 2331
s.g.agrawal@qmul.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00482716
Protocol/serial number
Version 2 (Oct 2006)
Study information
Scientific title
Acronym
High Iron Study
Study hypothesis
Parental iron will optimise the response to recombinant erythropoietin therapy in patients who are iron replete.
Ethics approval
Approval received from the East London and the City Research Ethics Committee on the 17th October 2006 (ref: 06/Q0605/93).
Study design
Randomised, controlled, open label, prospective trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Chemotherapy induced anaemia
Intervention
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)
Intervention type
Supplement
Phase
Not Specified
Drug names
Iron supplementation (Venefor), epoietin
Primary outcome measures
The primary outcome will be the maximum haemoglobin achieved during the conduct of the study.
Secondary outcome measures
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.
Overall trial start date
01/11/2006
Overall trial end date
24/04/2009
Reason abandoned
Participant recruitment issue
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Eighty patients
Participant 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
Recruitment start date
01/11/2006
Recruitment end date
24/04/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Barts and the London NHS Trust
London
EC1A 7BE
United Kingdom
Sponsor information
Organisation
Barts and the London NHS Trust (UK)
Sponsor details
Research and Development Department
3rd Floor Rutland House
42-46 New Road
Whitechapel
London
E1 2AX
United Kingdom
+44 (0)20 7882 7260
Gerry.Leonard@bartsandthelondon.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
St. Bartholomew's Hospital (UK) - internal funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary