NCT00122720

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for phase_4 colorectal-cancer

Timeline
Completed

Started Jun 2003

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

July 7, 2006

Status Verified

January 1, 2006

First QC Date

July 20, 2005

Last Update Submit

July 3, 2006

Conditions

Colorectal Cancer

Keywords

colorectal cancererythropoietinrehabilitationphysical capacity

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Darbepoetin AlfaDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Planned colonic and rectal surgery because of presumed cancer disease in the colon and rectum

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Surgical Department, Aarhus University Hospital

Aarhus, Aarhus, 8000, Denmark

Location

Surgical Department, Middelfart Hospital

Middelfart, Fyn, 5500, Denmark

Location

Surgical Department, Odense University Hospital

Odense, Fyn, 5000, Denmark

Location

Surgical Department, Svendborg Hospital

Svendborg, Fyn, 5700, Denmark

Location

Surgical Department, Herning Hospital

Herning, Ringkobing, 7400, Denmark

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Charlotte B Norager, M.D.

    Surgical Research Department, Herning Hospital, Gl. Landevej 61, DK-7400 Herning

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 20, 2005

First Posted

July 22, 2005

Study Start

June 1, 2003

Study Completion

January 1, 2006

Last Updated

July 7, 2006

Record last verified: 2006-01

Locations

DK(5)