The Effect of Darbepoetin Alfa Treatment Upon the Rehabilitation Following Planned Surgery for Colorectal Cancer
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
The functional capacity measured by postoperative fatigue, work capacity, balance, and quality of life
Charlotte B Norager, M.D.
Principal Investigator
Surgical Research Department, Herning Hospital, Gl. Landevej 61, DK-7400 Herning
Denmark: National Board of Health
2612-2277
NCT00122720
June 2003
January 2006
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