Conditions: Anemia
Keywords: Anemia Cancer Chemotherapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 224
Healthy volunteers: no

Brief summary:
To assess the change in hemoglobin levels when iron sucrose was added to a regimen of weekly, fixed doses of erythropoietin in patients who had or had not responded to erythropoietin therapy alone.

Detailed description:
This was a two stage, randomized, controlled study of cancer patients undergoing or planning to undergo chemotherapy. After stage one, (where patients were exposed to an erythropoiesis stimulating agent), patients were randomized to receive either IV iron sucrose or no iron supplementation. Patients were then followed to safety and efficacy endpoints.

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: iron sucrose injection USP intervention 2: stable erythropoietin therapy
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: