NCT07201194招募中不适用
HOL-AKU: Holistic Acupuncture for Patients With Chemotherapy Induced Nausea
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Patient reported nausea assessed on the EORTC-15-PAL Scale
研究概览
简要总结
The study explores whether acupuncture as a supplement to conventional antiemetic medicine is superior in reducing the level of chemotherapy induced nausea compared to conventional anitemetic medicine alone.
A total of 90 patients experiencing chemotherapy induced nausea will be allocated 1:1 to either acupuncture and antiemetic medicine or antiemetic medicine alone.
The level of nausea and other cancer related symptoms will be assessed at baseline and 8 and 22 days after enrollment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
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
- •≥ 18 years of age
- •Undergoing chemotherapy and experiencing nausea despite adherence to the prescribed antiemetic regimen
- •Understands and speaks Danish
- •Written and orally informed consent
- •Planned for treatment every 14 days
- •At least two chemotherapy cycles planned at the time of inclusion
排除标准
- •Brain metastases
- •Performance status >2
研究组 & 干预措施
Holistic acupuncture and acupressure
Experimental
Holistic acupuncture and acupressure as a supplement to standard care
干预措施: Holistic acupuncture and acupressure (Other)
Standard care
Active Comparator
干预措施: Standard medical treatment (Other)
结局指标
主要结局
Patient reported nausea assessed on the EORTC-15-PAL Scale
时间窗: 8 days after enrollment
次要结局
- Patient reported symptom intensity according to the EORTC-15 PAL Scale(8 and 22 days after enrollment)
研究者
研究点 (2)
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