NCT02980289已完成不适用
DAnish Nausea Study In Advanced Cancer-Epidemiology: A Danish Multicenter Trial to Investigate the Prevalence and Treatment of Nausea and/or Vomiting in Patients With Advanced Cancer.
Signe Harder1 个研究点 分布在 1 个国家目标入组 821 人开始时间: 2016年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 821
- 试验地点
- 1
- 主要终点
- 2-item nausea-score from EORTC-QLQ-C15-Pal at baseline and 1 week
研究概览
简要总结
The study aims to investigate the prevalence and treatment of nausea and/or vomiting in patients with advanced cancer not receiving chemotherapy or irradiation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced cancer
- •Age ≥ 18 years
- •Ability to read and understand the forms required for the study
- •Life-expectancy more than 2 weeks.
- •Nausea score ≥ 'a little' on the extended EORTC QLQ-C15-PAL (item 9)
排除标准
- •Surgery to the brain or abdomen within the last 2 weeks or exposure to general anesthesia within the last 4 days.
- •Chemotherapy or radiation therapy within the last 4 weeks
- •Symptoms of increased intracranial pressure or cerebral metastasis. If this is suspected, a normal MRI scan of the cerebrum is needed before inclusion
- •Radiologically confirmed ileus, or strong clinical suspicion evaluated by the study Investigator
结局指标
主要结局
2-item nausea-score from EORTC-QLQ-C15-Pal at baseline and 1 week
时间窗: From baseline and at 1 week (5-9 days)
The primary objective is to observe the effect of standard anti-emetics on change in two-item nausea-score from baseline to 24 hours.
次要结局
- Emesis at screening from EORTC-QLQ-C15-Pal at baseline(At baseline)
- Nausea CAT-score from EORTC-QLQ-C15-Pal at baseline and after 1 week(1 week (5-9 days))
- Nausea at screening from EORTC-QLQ-C15-Pal at baseline(At baseline)
- Change in other parameters from EORTC-QLQ-C15-Pal at baseline and after 1 week(From baseline and at 1 week (5-9 days))
研究者
Signe Harder
Doctor
Odense University Hospital
研究点 (1)
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