Colorectal CancerPhase 4NCT00122720
The Effect of Darbepoetin Upon Rehabilitation for Colorectal Cancer Surgery
A Phase 4 study testing Darbepoetin Alfa in people with Colorectal Cancer, run by Herning Hospital at 5 sites in Denmark.
Trial summary
The study is investigating whether randomization to perioperative darbepoetin alfa treatment improves the rehabilitation following surgery for colonic and rectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Darbepoetin Alfa
- How many people
- 200 participants
- Where
- 5 sitesDenmark
- Study dates
- Jun 2003to Jan 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned colonic and rectal surgery because of presumed cancer disease in the colon and rectum
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites
Surgical Department, Aarhus University Hospital
Aarhus, Aarhus, 8000
Surgical Department, Herning Hospital
Herning, Ringkobing, 7400
Surgical Department, Middelfart Hospital
Middelfart, Fyn, 5500
Surgical Department, Odense University Hospital
Odense, Fyn, 5000
Surgical Department, Svendborg Hospital
Svendborg, Fyn, 5700
About this study
Official title: The Effect of Darbepoetin Alfa Treatment Upon the Rehabilitation Following Planned Surgery for Colorectal Cancer
The study is investigating whether randomization to perioperative darbepoetin alfa treatment improves the rehabilitation following surgery for colonic and rectal cancer.
Read the 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
- Being tested
- Darbepoetin Alfa
- Keywords
- colorectal cancer, erythropoietin, rehabilitation, physical capacity
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darbepoetin AlfaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The functional capacity measured by postoperative fatigue, work capacity, balance, and quality of life
Secondary outcomes (5)
Muscular strength
Weight
Body composition
Blood transfusion
Postoperative complications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startJun 2003
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Herning Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Investigators
- Charlotte B Norager, M.D., Principal investigator, Surgical Research Department, Herning Hospital, Gl. Landevej 61, DK-7400 Herning
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00122720
- Sponsor's protocol ID
- 2612-2277
- Status last verified
- Jan 2006
- First submitted
- 20 Jul 2005
- Last updated
- 7 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Darbepoetin Alfa Treatment Upon the Rehabilitation Following Planned Surgery for Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00122720
- Acronym / sponsor ID
- 2612-2277
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, erythropoietin, rehabilitation, physical capacity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Herning HospitalUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- Jun 2003
- Study completion
- Jan 2006
- First posted
- 22 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Planned colonic and rectal surgery because of presumed cancer disease in the colon and rectum
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Darbepoetin Alfa | Drug | – |
Primary outcome
The functional capacity measured by postoperative fatigue, work capacity, balance, and quality of life
5 secondary outcomes
Muscular strength
Weight
Body composition
Blood transfusion
Postoperative complications
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2006.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte B Norager, M.D. principal investigator
Surgical Research Department, Herning Hospital, Gl. Landevej 61, DK-7400 Herning
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Darbepoetin Alfa in people with Colorectal Cancer, run by Herning Hospital at 5 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The functional capacity measured by postoperative fatigue, work capacity, balance, and quality of life. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2006.