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


Phase 1
18 Years
N/A
Not Enrolling
Both
Anemia

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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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

1,4,8 and between 20 and 30 days post op

Safety Issue:

No

Principal Investigator

Stephen R. Grobmyer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Florida Division of Surgical Oncology and Endocrine Surgery

Authority:

United States: Food and Drug Administration

Study ID:

EPOSUR

NCT ID:

NCT00294203

Start Date:

February 2006

Completion Date:

Related Keywords:

  • Anemia
  • Digestive System Surgical Procedures
  • Post-Operative Care
  • Fatigue
  • Quality of Life
  • Erythrocyte Transfusion
  • Esophagectomy
  • Gastric Cancer
  • Hepatectomy
  • Pancreatic Cancer
  • Rectum
  • Anemia

Name

Location

University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Shands Hospital at the University of FloridaGainesville, Florida  32610