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The Effect of Darbepoetin Upon Rehabilitation for Colorectal Cancer Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00122720
Recruitment Status : Completed
First Posted : July 22, 2005
Last Update Posted : July 7, 2006
Information provided by:
Herning Hospital

Brief Summary:
The study is investigating whether randomization to perioperative darbepoetin alfa treatment improves the rehabilitation following surgery for colonic and rectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Darbepoetin Alfa Phase 4

Detailed Description:

Major surgery elicits a metabolic stress response that is followed by a loss of body mass, fatigue, and an impaired physical performance including a reduced work capacity.

To perform ordinary daily activities many elderly people exert close to their maximum physical capacity, and even a small reduction of performance capacity may cause significant impairment in physical and social activity. Postoperative decline in strength and work capacity may thus cause previously independent living persons to become dependent upon assistance from others. Hence, it is important to avoid the postoperative reduction of physical performance and to minimize postoperative fatigue.

It has been shown that Erythropoietin treatment reduces the need for blood transfusions in patients undergoing planned colonic surgery. However, the effect of Erythropoietin treatment upon postoperative rehabilitation has not yet been studied.

Therefore the main hypothesis in this study is that perioperative treatment with Darbepoetin Alfa would improve the physical capacity in aspects by reducing postoperative fatigue and improve work capacity, balance and quality of life compared to placebo treatment. Furthermore, the researchers expect Darbepoetin treated patients to have fewer perioperative complications and less need for blood transfusions.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Effect of Darbepoetin Alfa Treatment Upon the Rehabilitation Following Planned Surgery for Colorectal Cancer
Study Start Date : June 2003
Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. The functional capacity measured by postoperative fatigue, work capacity, balance, and quality of life

Secondary Outcome Measures :
  1. Muscular strength
  2. Weight
  3. Body composition
  4. Blood transfusion
  5. Postoperative complications

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Planned colonic and rectal surgery because of presumed cancer disease in the colon and rectum

Exclusion Criteria:

  • Psychiatric disease or dementia
  • Diseases, that renders participation in the study impossible
  • Thromboembolic disease within the last three months
  • Dysregulated hypertension (systolic blood pressure>175 mmHg and/or diastolic blood pressure>105 mmHg)
  • Other diseases or causes that will contraindicate treatment with Darbepoetin Alfa
  • Other diseases or causes that will contraindicate further treatment with Darbepoetin Alfa
  • Patients that preoperatively and/or four days postoperatively have a hemoglobin concentration > 14 g/dl
  • Former cancer disease
  • Disseminated cancer disease
  • Rectal cancer stage T4

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 identifier (NCT number): NCT00122720

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Surgical Department, Middelfart Hospital
Middelfart, Fyn, Denmark, 5500
Surgical Department, Odense University Hospital
Odense, Fyn, Denmark, 5000
Surgical Department, Svendborg Hospital
Svendborg, Fyn, Denmark, 5700
Surgical Department, Herning Hospital
Herning, Ringkobing, Denmark, 7400
Surgical Department, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
Herning Hospital
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Principal Investigator: Charlotte B Norager, M.D. Surgical Research Department, Herning Hospital, Gl. Landevej 61, DK-7400 Herning

Layout table for additonal information Identifier: NCT00122720     History of Changes
Other Study ID Numbers: 2612-2277
First Posted: July 22, 2005    Key Record Dates
Last Update Posted: July 7, 2006
Last Verified: January 2006

Keywords provided by Herning Hospital:
colorectal cancer
physical capacity

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Darbepoetin alfa