Status:
COMPLETED
The Effect of Darbepoetin Upon Rehabilitation for Colorectal Cancer Surgery
Lead Sponsor:
Herning Hospital
Collaborating Sponsors:
Amgen
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The study is investigating whether randomization to perioperative darbepoetin alfa treatment improves the rehabilitation following surgery for colonic and rectal cancer.
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 a...
Eligibility Criteria
Inclusion
- Planned colonic and rectal surgery because of presumed cancer disease in the colon and rectum
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00122720
Start Date
June 1 2003
End Date
January 1 2006
Last Update
July 7 2006
Active Locations (5)
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1
Surgical Department, Aarhus University Hospital
Aarhus, Aarhus, Denmark, 8000
2
Surgical Department, Middelfart Hospital
Middelfart, Fyn, Denmark, 5500
3
Surgical Department, Odense University Hospital
Odense, Fyn, Denmark, 5000
4
Surgical Department, Svendborg Hospital
Svendborg, Fyn, Denmark, 5700