Inhalation Approaches to Nausea: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Change in nausea
研究概览
简要总结
The goal of this research study is to understand the effect of inhalation approaches in reducing nausea in cancer patients.
详细描述
In this study, inhalation of a study solution will be compared to inhalation of placebo, both in the form of preparation pads (a small square of material that contains the solution). Isopropyl alcohol may be a part of the preparation pads. A placebo is not a drug. It looks like the study solution but is not designed to treat any disease or illness. It is designed to be compared with the study solution to learn if the study solution has any real effect.
Inhalation of the study solution may help to control your nausea. Future patients may benefit from what is learned. There may be no benefits for you in this study.
Your participation is completely voluntary. Before choosing to take part in this study, you should discuss with the study team any concerns you may have, including side effects, potential expenses, and time commitment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None (Participant)
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
- •Rate current severity of acute/chronic nausea >= 4 on NRS (Numeric Rating Scale)
- •Diagnosis of cancer
- •Able to read/write in English
- •Referred to supportive care service as an inpatient or outpatient
- •Rate anxiety as =< 4 on ESAS-FS (Edmonton Symptom Assessment Scale-Financial Distress and Spiritual Pain)
- •Participants must agree to inhale isopropyl alcohol
排除标准
- •Received anti-emetics in the last 30 minutes
- •Received medical procedures (e.g. blood draws) which required exposure of isopropyl alcohol in the last 30 minutes
- •Inability to inhale through nares (including recent upper respiratory infection)
- •Known allergy to isopropyl alcohol
- •Delirium (i.e., score >= 7 on the Memorial Delirium Assessment Scale [MDAS])
- •Have never been on anti-emetics during the course of the treatment here (anti-emetic naive)
研究组 & 干预措施
Arm I (isopropyl alcohol)
Patients receive isopropyl alcohol via nasal inhalation.
干预措施: Isopropyl Alcohol (Drug)
Arm II (placebo)
Patients receive placebo via nasal inhalation.
干预措施: Questionnaire Administration (Other)
Arm I (isopropyl alcohol)
Patients receive isopropyl alcohol via nasal inhalation.
干预措施: Questionnaire Administration (Other)
Arm II (placebo)
Patients receive placebo via nasal inhalation.
干预措施: Placebo (Other)
结局指标
主要结局
Change in nausea
时间窗: Baseline up to 5 minutes post-intervention
The mean change in nausea level will be compared between the two arms by two sample t-test. In case there's any violation in the underlying assumptions (e.g. normality, equality of variance, etc.) proper transformation (e.g. logarithm, square root, etc.) or non-parametric methods (Wilcoxon rank sum test) will be applied.
次要结局
未报告次要终点