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

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2002
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. CONDITION: Anaemia ; Haematological Disorders ; Anaemia in chronic diseases classified elsewhere PRIMARY OUTCOME: Not provided at time of registration SECONDARY OUTCOME: Not provided at time of registration 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
Epistemonikos ID: 8576d0b68a8d3835c3e2830e6ba60dcf89574f23
First added on: Aug 21, 2024