The Effect of Darbepoetin Upon Rehabilitation for Colorectal Cancer Surgery

Sponsor

Herning Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00122720

Collaborator

Amgen (Industry)

200

Enrollment

Locations

Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Drug: Darbepoetin Alfa	Phase 4

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2003

Study Completion Date :

Jan 1, 2006

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Muscular strength []
Weight []
Body composition []
Blood transfusion []
Postoperative complications []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Surgical Department, Middelfart Hospital	Middelfart	Fyn	Denmark	5500
2	Surgical Department, Odense University Hospital	Odense	Fyn	Denmark	5000
3	Surgical Department, Svendborg Hospital	Svendborg	Fyn	Denmark	5700
4	Surgical Department, Herning Hospital	Herning	Ringkobing	Denmark	7400
5	Surgical Department, Aarhus University Hospital	Aarhus		Denmark	8000