Pilot Study of Epoetin Alfa for Patients Having Abdominal or Pelvic Surgery for Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

February 28, 2006

Primary Completion Date

December 31, 2008

Study Completion Date

December 31, 2008

Conditions
Anemia
Interventions
DRUG

Epoetin Alfa group

Patients enrolled in the study will be randomized to receive either 40,000 units of epoetin alfa on day 1 and day 8. 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.

OTHER

Placebo group

Patients enrolled in the study will be randomized to receive either 40,000 units of placebo (saline) on day 1 and day 8. 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.

Trial Locations (2)

32610

Shands Hospital at the University of Florida, Gainesville

University of Florida Shands Cancer Center, Gainesville

All Listed Sponsors
collaborator

Ortho Biotech Clinical Affairs, L.L.C.

INDUSTRY

lead

University of Florida

OTHER

NCT00294203 - Pilot Study of Epoetin Alfa for Patients Having Abdominal or Pelvic Surgery for Cancer | Biotech Hunter | Biotech Hunter