Clinical trial NCT00294203: Pilot Study of Epoetin Alfa for Patients Having Abdominal or Pelvic Surgery for Cancer
Official title: Placebo-Controlled Pilot Study to Assess the Post-Operative Administration of Epoetin Alfa on Patients Undergoing Abdominal or Pelvic Surgery for Malignancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anemia
Keywords: Digestive System Surgical Procedures
Post-Operative Care
Fatigue
Quality of Life
Erythrocyte Transfusion
Esophagectomy
Gastric Cancer
Hepatectomy
Pancreatic Cancer
Rectum
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Ortho Biotech Clinical Affairs, L.L.C.
First posted: 2006-02-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
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
timeFrame: 1,4,8 and between 20 and 30 days post op
Secondary outcomes:
measure: 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
timeFrame: between 20 and 30 days postop
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Shands Hospital at the University of Florida
state: Florida
city: Gainesville
country: United States
facility: University of Florida Shands Cancer Center
state: Florida
Study officials:
affiliation: University of Florida Division of Surgical Oncology and Endocrine Surgery
name: Stephen R. Grobmyer, MD
role: PRINCIPAL_INVESTIGATOR
References: