The Effect of Darbepoetin Upon Rehabilitation for Colorectal Cancer Surgery

Herning Hospital

Status and phase

Completed

Phase 4

Conditions

Colorectal Cancer

Treatments

Drug: Darbepoetin Alfa

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00122720

2612-2277

Details and patient eligibility

About

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

Full description

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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