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Completed

NCT Number: NCT00294203

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shands Hospital at the University of Florida, Gainesville, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Epoetin Alfa group

Drug

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.

Placebo Group

Other

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.

Other names: saline

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

    Time frame: 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

    Time frame: between 20 and 30 days postop

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Ortho Biotech Clinical Affairs, L.L.C.

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Feb 20, 2006
Registry last updated
Apr 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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