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Completed

NCT Number: NCT00122720

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Surgical Department, Aarhus University Hospital, Aarhus, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

darbepoetin alfa

Drug

Primary outcomes

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

Secondary outcomes

  1. Muscular strength

  2. Weight

  3. Body composition

  4. Blood transfusion

  5. Postoperative complications

Sponsors and collaborators

Lead sponsor

Herning Hospital

Other

Collaborators

  • Amgen

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2006
First posted
Jul 22, 2005
Registry last updated
Jul 7, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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