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临床试验/NCT00122720
NCT00122720已完成4 期

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

Herning Hospital10 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2003年6月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
200
试验地点
10
主要终点
The functional capacity measured by postoperative fatigue, work capacity, balance, and quality of life

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

The functional capacity measured by postoperative fatigue, work capacity, balance, and quality of life

次要结局

  • Muscular strength
  • Weight
  • Body composition
  • Blood transfusion
  • Postoperative complications

研究者

发起方
Herning Hospital
申办方类型
Other

研究点 (10)

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