Clinical trial NCT00122720: The Effect of Darbepoetin Upon Rehabilitation for Colorectal Cancer Surgery
Official title: The Effect of Darbepoetin Alfa Treatment Upon the Rehabilitation Following Planned Surgery for Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colorectal Cancer
Keywords: colorectal cancer
erythropoietin
rehabilitation
physical capacity
Lead sponsor: Herning Hospital
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2005-07-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The functional capacity measured by postoperative fatigue, work capacity, balance, and quality of life
Secondary outcomes:
measure: Muscular strength
measure: Weight
measure: Body composition
measure: Blood transfusion
measure: Postoperative complications
Other outcomes:
Locations:
city: Middelfart
country: Denmark
facility: Surgical Department, Middelfart Hospital
state: Fyn
city: Odense
country: Denmark
facility: Surgical Department, Odense University Hospital
state: Fyn
city: Svendborg
country: Denmark
facility: Surgical Department, Svendborg Hospital
state: Fyn
city: Herning
country: Denmark
facility: Surgical Department, Herning Hospital
state: Ringkobing
city: Aarhus
country: Denmark
facility: Surgical Department, Aarhus University Hospital
Study officials:
affiliation: Surgical Research Department, Herning Hospital, Gl. Landevej 61, DK-7400 Herning
name: Charlotte B Norager, M.D.
role: PRINCIPAL_INVESTIGATOR
References: