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

Phase 4
18 Years
Not Enrolling
Colorectal Cancer

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Trial Information

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.

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

The functional capacity measured by postoperative fatigue, work capacity, balance, and quality of life

Principal Investigator

Charlotte B Norager, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Surgical Research Department, Herning Hospital, Gl. Landevej 61, DK-7400 Herning


Denmark: National Board of Health

Study ID:




Start Date:

June 2003

Completion Date:

January 2006

Related Keywords:

  • Colorectal Cancer
  • colorectal cancer
  • erythropoietin
  • rehabilitation
  • physical capacity
  • Colorectal Neoplasms