| Source of record | UK Trials |
| ISRCTN | ISRCTN98318971 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | GN308 |
| Public title | A double-blind, placebo controlled study to assess the effects of early intervention and/or treatment with epoetin alfa on anaemia in cancer patients receiving non platinum containing chemotherapy |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Anaemia in cancer patients |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Diagnosis of non-myeloid malignancy, which requires non platinum containing chemotherapy
2. Predicted chemotherapy of 12 to 24 weeks (three to six cycles) duration
3. Performance score zero to three
4. Life expectancy of more than six months
5. Aged over 18 years
6. Patients with acute leukaemia are excluded
7. No myeloablative chemotherapy
8. No uncontrolled hypertension
9. No evidence of untreated iron, folate or vitamin B12 deficiency |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Patients are randomised to one of two treatment arms:
1. Arm A: Patients receive 150 IU/Kg of Epoetin alpha
2. Arm B: Patients receive matching placebo Epoetin alpha or placebo is given subcutaneously three times per week for the first four weeks (or the first on-study chemotherapy cycle, respectively). Haemaglobin level and/or reticulocyte count will then be used to determine whether the same dose (volume) or a doubled dose (volume) will be used for the remainder of the treatment. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Janssen-Cilag Ltd |
| Sponsor name | Janssen-Cilag Ltd |
| Sponsor details | Saunderton
High Wycombe
United Kingdom
HP14 4HJ |
| Sponsor telephone | +44 (0) 1494 567567 |
| Sponsor website | http://www.janssen-cilag.co.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN98318971 |
| Date last extracted from ISRCTN register | 17/04/2008 |
