Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122720
Status:
COMPLETED
Last Update Posted:
2006-07-07
First Post:
2005-07-20
Brief Title:
The Effect of Darbepoetin Upon Rehabilitation for Colorectal Cancer Surgery
Sponsor:
Herning Hospital
Organization:
Herning Hospital
Study Overview
Official Title:
The Effect of Darbepoetin Alfa Treatment Upon the Rehabilitation Following Planned Surgery for Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2006-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None