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临床试验/NCT04342780
NCT04342780已完成不适用

Delayed Chemotherapy-induced Nausea: A Multi-center Prevalence Survey in Adult Oncology Patients in Clinical Practice

Antje Koller1 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2020年6月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
172
试验地点
1
主要终点
delayed Nausea

研究概览

简要总结

This study evaluates the prevalence of delayed chemotherapy induced nausea in adult oncology patients in real clinical practice of day clinics.

详细描述

Chemotherapies are rated to have a high to minimal emetogenic potential in oncology patients. Their potential to induce delayed nausea is supposed to often be higher than their emetogenic potential. However, data on delayed chemotherapy-related nausea are scarce, which is problematic because nausea (a) has a large impact on patients quality of life and treatment decisions, (b) is often underestimated by health care professionals, (c) is less responsive to commonly used antiemetic medication, and (d) may even be different from rates that have been established in controlled clinical trials.

Therefore, the aim of this study is to assess the prevalence of delayed chemotherappy-induced nausea in adult oncology patients in dayclinics.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • first day of chemotherapy of a new cycle (any cycle)
  • speak and write German
  • sign the consent forms

排除标准

  • cognitive or linguistic impairments that would significantly impede consent or participation (as assessed by the nurses in charge)
  • accompanying radiotherapy;
  • pre-existing nausea within three days before the start of the first chemotherapy in this cycle; and
  • prior participation in CINrate (each person participates only once)

结局指标

主要结局

delayed Nausea

时间窗: Each patient: each days for 5 days after chemotherapy; recruitment: six weeks

nausea that occurs 24 hours to 5 days after chemotherapy (100mm VAS in diary)

次要结局

  • acute and delayed vomiting(Each patient: each day for 5 days after chemotherapy; recruitment: six weeks)
  • interference of nausea or vomiting with everyday life(Each patient: measured at day 5 after chemotherapy; recruitment: six weeks)
  • adherence to antiemetics(Each patient: each day for 5 days after chemotherapy; recruitment: six weeks)
  • antiemetic prescription(Each patient: at day of chemotherapy at discharge from dayclinic; recruitment: six weeks)
  • patient-related barriers to antiemetics(Each patient: measured at day 5 after chemotherapy; recruitment: six weeks)
  • acute nausea(Each patient: at day of chemotherapy at discharge from dayclinic; recruitment: six weeks)

研究者

发起方
Antje Koller
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Antje Koller

Principal Investigator

St.Gallen University of Applied Sciences

研究点 (1)

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