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 |
| Protocol serial number | NTR250 |
| Sponsor | Vrije University Medical Centre (VUMC) (The Netherlands) |
| Funder | Vrije University Medical Centre (VUMC) (The Netherlands) |
- 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
Scientific
VU Medical Centre
Principal Investigator Medical Oncology
6 Z 170
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
| Phone | +31 (0)20 4444321 |
|---|---|
| g.giaccone@vumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre, randomised, active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To 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) studied | Anaemia |
| Intervention | Epoetin alfa, iron (III)-hydroxyde-sucrose, ferrofumarate. |
| Intervention type | Supplement |
| Primary outcome measure(s) |
Increase in Hb |
| Key secondary outcome measure(s) |
1. Number of required blood transfusions |
| Completion date | 30/07/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 34 |
| Key inclusion criteria | 1. 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 criteria | 1. 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 enrolment | 01/02/2001 |
| Date of final enrolment | 30/07/2003 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
VU Medical Centre
Amsterdam
1007 MB
Netherlands
1007 MB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
