The Effect of Darbepoetin Upon Rehabilitation for Colorectal Cancer Surgery

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00122720
• Other study ID #: 2612-2277
• Status: Completed
• Phase: Phase 4
• First received: July 20, 2005
• Last updated: July 3, 2006
• Start date: June 2003
• Est. completion date: January 2006

Study information

• Verified date: January 2006
• Source: Herning Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Darbepoetin Alfa

Locations

Country	Name	City	State
Denmark	Surgical Department, Aarhus University Hospital	Aarhus
Denmark	Surgical Department, Herning Hospital	Herning	Ringkobing
Denmark	Surgical Department, Middelfart Hospital	Middelfart	Fyn
Denmark	Surgical Department, Odense University Hospital	Odense	Fyn
Denmark	Surgical Department, Svendborg Hospital	Svendborg	Fyn

Sponsors (2)

Lead Sponsor	Collaborator
Herning Hospital	Amgen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The functional capacity measured by postoperative fatigue, work capacity, balance, and quality of life
Secondary	Muscular strength
Secondary	Weight
Secondary	Body composition
Secondary	Blood transfusion
Secondary	Postoperative complications