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

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ClinicalTrials.gov Identifier: NCT00294203
Recruitment Status : Completed
First Posted : February 20, 2006
Last Update Posted : April 15, 2014
Sponsor:
Collaborator:
Ortho Biotech Clinical Affairs, L.L.C.
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment Phase
Anemia Drug: Epoetin Alfa group Other: Placebo group Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : February 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arm Intervention/treatment
Active Comparator: Epoetin Alfa group
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.
Drug: Epoetin Alfa group
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 Comparator: Placebo group
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: Placebo group
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 Name: saline




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00294203


Locations
United States, Florida
Shands Hospital at the University of Florida
Gainesville, Florida, United States, 32610
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Ortho Biotech Clinical Affairs, L.L.C.
Investigators
Principal Investigator: Stephen R. Grobmyer, MD University of Florida Division of Surgical Oncology and Endocrine Surgery

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00294203     History of Changes
Other Study ID Numbers: EPOSUR
20052318
First Posted: February 20, 2006    Key Record Dates
Last Update Posted: April 15, 2014
Last Verified: April 2014

Keywords provided by University of Florida:
Digestive System Surgical Procedures
Post-Operative Care
Fatigue
Quality of Life
Erythrocyte Transfusion
Esophagectomy
Gastric Cancer
Hepatectomy
Pancreatic Cancer
Rectum

Additional relevant MeSH terms:
Epoetin Alfa
Hematinics