The Effect of Darbepoetin Upon Rehabilitation for Colorectal Cancer Surgery
The study is investigating whether randomization to perioperative darbepoetin alfa treatment improves the rehabilitation following surgery for colonic and rectal cancer.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||The Effect of Darbepoetin Alfa Treatment Upon the Rehabilitation Following Planned Surgery for Colorectal Cancer|
- The functional capacity measured by postoperative fatigue, work capacity, balance, and quality of life
- Muscular strength
- Body composition
- Blood transfusion
- Postoperative complications
|Study Start Date:||June 2003|
|Estimated Study Completion Date:||January 2006|
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.
|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|
|Principal Investigator:||Charlotte B Norager, M.D.||Surgical Research Department, Herning Hospital, Gl. Landevej 61, DK-7400 Herning|