Trial Information

Placebo-Controlled Pilot Study to Assess the Post-Operative Administration of Epoetin Alfa on Patients Undergoing Abdominal or Pelvic Surgery for Malignancy

This is a pilot, single center, prospective, double blinded, randomized study comparing
epoetin alfa versus placebo. Eligible patients will just have undergone a major abdominal
operation for malignancy (esophagectomy, gastrectomy, partial hepatectomy, partial
pancreatectomy, or low anterior resection of rectum) and have a post-operative hemoglobin
greater than 8 g/dL and less than 11 g/dL on post-operative day #1. On post-operative day #1
patients enrolled in the study will be randomized to receive either 40,000 units of epoetin
alfa or placebo. On post-operative day #8, the patients will receive an additional dose of
epoetin alfa or placebo (depending on randomization assignment and Hgb level). Hemoglobin,
hematocrit, reticulocyte count, reticulocyte hemoglobin, and immature reticulocyte count
will be measured on days 1, 4, 8, and once between post-operative days 20 and 30.
Pre-operatively and between post-operative days 20 and 30 patients will complete a quality
of live assessment tool (FACT-An) to assess their fatigue related to anemia.