The Effect of Darbepoetin Upon Rehabilitation for Colorectal Cancer Surgery

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

Detailed Description
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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.

Official Title
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The Effect of Darbepoetin Alfa Treatment Upon the Rehabilitation Following Planned Surgery for Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: Darbepoetin Alfa


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Darbepoetin Alfa|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The functional capacity measured by postoperative fatigue, work capacity, balance, and quality of life |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscular strength |  |  | 
| Weight |  |  | 
| Body composition |  |  | 
| Blood transfusion |  |  | 
| Postoperative complications |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer, erythropoietin, rehabilitation, physical capacity