The Effect of Darbepoetin Upon Rehabilitation for Colorectal Cancer Surgery

This study has been completed.
Sponsor:
Collaborator:
Amgen
Information provided by:
Herning Hospital
ClinicalTrials.gov Identifier:
NCT00122720
First received: July 20, 2005
Last updated: July 3, 2006
Last verified: January 2006
  Purpose

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


Condition Intervention Phase
Colorectal Cancer
Drug: Darbepoetin Alfa
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Effect of Darbepoetin Alfa Treatment Upon the Rehabilitation Following Planned Surgery for Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Herning Hospital:

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

Estimated Enrollment: 200
Study Start Date: June 2003
Estimated Study Completion Date: January 2006
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00122720

Locations
Denmark
Surgical Department, Middelfart Hospital
Middelfart, Fyn, Denmark, 5500
Surgical Department, Odense University Hospital
Odense, Fyn, Denmark, 5000
Surgical Department, Svendborg Hospital
Svendborg, Fyn, Denmark, 5700
Surgical Department, Herning Hospital
Herning, Ringkobing, Denmark, 7400
Surgical Department, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
Herning Hospital
Amgen
Investigators
Principal Investigator: Charlotte B Norager, M.D. Surgical Research Department, Herning Hospital, Gl. Landevej 61, DK-7400 Herning
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00122720     History of Changes
Other Study ID Numbers: 2612-2277
Study First Received: July 20, 2005
Last Updated: July 3, 2006
Health Authority: Denmark: National Board of Health

Keywords provided by Herning Hospital:
colorectal cancer
erythropoietin
rehabilitation
physical capacity

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014