Randomized Controlled Study of Iron Supplementation to Support the Response to Recombinant Human Erythropoietin for the Treatment of Chemotherapy-Induced Anaemia
- Compare the efficacy of recombinant epoetin alfa or epoetin beta with vs without
parenteral iron in anemic, iron-replete patients with nonmyeloid malignancies.
OUTLINE: This is a randomized, controlled, open-label, prospective study. Patients are
randomized to 1 of 2 treatment arms.
- Arm I: Patients receive recombinant erythropoietic stimulatory activity (ESA) therapy
comprising epoetin alfa or epoetin beta subcutaneously (SC) on day 1.
- Arm II: Patients receive ESA therapy as in arm I and parenteral iron (i.e., low
molecular weight iron dextran complex IV over 5-10 minutes or iron sucrose injection IV
over 10-30 minutes) on day 1.
In both arms, treatment repeats weekly for up to 10 weeks or until hemoglobin reaches 13
g/dL, whichever comes first.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care
Maximum hemoglobin achieved
Samir G Agrawal, MD, PhD
St. Bartholomew's Hospital
United States: Federal Government