Clinical trial · Interventional
Pilot Study of Epoetin Alfa for Patients Having Abdominal or Pelvic Surgery for Cancer
Placebo-Controlled Pilot Study to Assess the Post-Operative Administration of Epoetin Alfa on Patients Undergoing Abdominal or Pelvic Surgery for Malignancy
NCT00294203CI-TRIAL-00014257completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This pilot study is looking at how well epoetin alfa, given in the immediate post-operative period, works in reducing anemia and the need for transfusions.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epoetin Alfa group | Drug | — | UNRESOLVED |
| Placebo group | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Epoetin Alfa group
- description
- 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.
- interventionNames
- Drug: Epoetin Alfa group
- type
- PLACEBO_COMPARATOR
- label
- Placebo group
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients undergoing esophagectomy, gastrectomy, partial pancreatectomy, hepatic resection, or low anterior resection of rectum for malignancy * Patients with hemoglobin greater than 8 and less than 11 g/dL on post-operative day #1. Exclusion Criteria: * Patients receiving red blood cell transfusion within the first twelve hours post-operatively. * Patients receiving epoetin-stimulating proteins within 30 days prior to the operation.
References
Publications (0)
Data not yet available
No reference posted for this study.