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

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

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Anaemia
Intervention	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.
Intervention type	Other
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/01/2004

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Key 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
Key exclusion criteria	Does not comply with the above inclusion criteria
Date of first enrolment	01/01/2003
Date of final enrolment	01/01/2004

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan