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
2 other identifiers
interventional
40
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2006
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 17, 2006
CompletedFirst Posted
Study publicly available on registry
February 20, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedApril 15, 2014
April 1, 2014
2.8 years
February 17, 2006
April 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post-operative hemoglobin, reticulocyte count, reticulocyte hemoglobin, and immature reticulocyte fraction measured on post-operative days 1, 4, 8, and between days 20 and 30
1,4,8 and between 20 and 30 days post op
Secondary Outcomes (1)
Post-operative quality of life related to anemia measured by Functional Assessment of Cancer Therapy - Anemia (FACT-An) between post-operative day 20 and 30 and post-operative transfusion requirement
between 20 and 30 days postop
Study Arms (2)
Epoetin Alfa group
ACTIVE COMPARATORPatients 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.
Placebo group
PLACEBO COMPARATORPatients 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- Ortho Biotech Clinical Affairs, L.L.C.collaborator
Study Sites (2)
Shands Hospital at the University of Florida
Gainesville, Florida, 32610, United States
University of Florida Shands Cancer Center
Gainesville, Florida, 32610, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen R. Grobmyer, MD
University of Florida Division of Surgical Oncology and Endocrine Surgery
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2006
First Posted
February 20, 2006
Study Start
February 1, 2006
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
April 15, 2014
Record last verified: 2014-04