Randomised study on haemoglobin response in iron-deficient anaemic patients with solid malignancies receiving epoetin alfa (rHuEPO) in combination with either oral or parental iron supplementation during treatment with non-platinum containing chemotherapy

ISRCTN ISRCTN61345286
DOI https://doi.org/10.1186/ISRCTN61345286
Secondary identifying numbers NTR250
Submission date
20/12/2005
Registration date
20/12/2005
Last edited
15/08/2008
Recruitment status
No longer recruiting
Overall study status
Completed
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

Prof Giuseppe Giaccone
Scientific

VU Medical Centre
Principal Investigator Medical Oncology
6 Z 170
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Phone +31 (0)20 4444321
Email g.giaccone@vumc.nl

Study information

Study designMulticentre, randomised, active controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesTo determine optimal route of iron supplementation during treatment with non-platinum containing chemotherapy for solid tumours.
Ethics approval(s)Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studiedAnaemia
InterventionEpoetin alfa, iron (III)-hydroxyde-sucrose, ferrofumarate.
Intervention typeSupplement
Primary outcome measureIncrease in Hb
Secondary outcome measures1. Number of required blood transfusions
2. Total dose of administered recombinant human erythropoietin alpha (rHuEPO)
Overall study start date01/02/2001
Completion date30/07/2003

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants34
Key inclusion criteria1. Confirmed diagnosis of a solid malignancy and planned to receive further non-platinum containing chemotherapy for at least 12 weeks
2. Haemoglobin (Hb) less than or equal to 7.5 mmol/L at any time during chemotherapy
3. Transferrin saturation (TSAT) less than 20% and/or serum ferritin less than 100 ng/ml
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
5. Life expectancy at least 3 months
6. Aged between 18 - 75 years
7. Sex: male or female. Female subjects must be either postmenopausal (for at least for 1 year), sterilised or, if of childbearing potential, be practising an acceptable method of birth control.
8. Subjects must have read and signed the informed consent form
Key exclusion criteria1. Mean corpuscular volume (MCV) less than 80 fL and mean corpuscular haemoglobin count (MCHC) less than 195 mmol/L
2. MCV greater than 100 fL
3. Clinically significant chronic blood loss
4. Clinically significant disease/dysfunction of the pulmonary, cardiovascular, endocrine, neurological, gastrointestinal, or genitourinary systems not attributable to underlying malignancy or chemotherapy. This dysfunction is only an exclusion criteria if it causes an expected early withdrawal from the study.
5. Uncontrolled hypertension, defined as a diastolic blood pressure greater than 100 mmHg, despite antihypertensive medication
6. History of seizures
7. Known hypersensitivity to Epoetin alfa or one of its components
8. Administration of intravenous iron preparations within 3 months before study entry
9. Participation in any other clinical trial involving unlicensed medication or procedures
10. Androgen therapy within two months of study entry
Date of first enrolment01/02/2001
Date of final enrolment30/07/2003

Locations

Countries of recruitment

  • Netherlands

Study participating centre

VU Medical Centre
Amsterdam
1007 MB
Netherlands

Sponsor information

Vrije University Medical Centre (VUMC) (The Netherlands)
University/education

Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Website http://www.vumc.nl
ROR logo "ROR" https://ror.org/00q6h8f30

Funders

Funder type

University/education

Vrije University Medical Centre (VUMC) (The Netherlands)

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