The Effect of Darbepoetin Upon Rehabilitation for Colorectal Cancer Surgery

NCT ID: NCT00122720

Last Updated: 2006-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2006-01-31

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.

Conditions

Colorectal Cancer

Keywords

colorectal cancer; erythropoietin; rehabilitation; physical capacity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Darbepoetin Alfa

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: collaborator

Herning Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Charlotte B Norager, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Surgical Department, Aarhus University Hospital

Aarhus, Aarhus, Denmark

Surgical Department, Middelfart Hospital

Middelfart, Fyn, Denmark

Surgical Department, Odense University Hospital

Odense, Fyn, Denmark

Surgical Department, Svendborg Hospital

Svendborg, Fyn, Denmark

Surgical Department, Herning Hospital

Herning, Ringkobing, Denmark

Countries

Denmark

Other Identifiers

2612-2277

Identifier Type: -

Identifier Source: org_study_id