跳至主要内容
临床试验/NCT02767791
NCT02767791已完成不适用

Auriculotherapy and Acupuncture's Treatment for Chemotherapy-induced Nausea and Vomiting (CINV)

Hopital Foch7 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2016年5月4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
Hopital Foch
入组人数
116
试验地点
7
主要终点
Digital Scale for nausea

研究概览

简要总结

The management of chemotherapy-induced nausea and vomiting (CINV) has evolved in recent years and became less frequent. CINV include early (occurring within 24 hours of chemotherapy administration) and delayed (occurring within 4 days after chemotherapy) nausea and vomiting.

Preventive treatment, such as Glucocorticoids, 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists and neurokinin 1 (NK1) receptor antagonists, are administered according to the classification in 4 grades of expected CINV

  • Very low: <10% occurrence of CINV;
  • Low: 10 to 30% occurrence of CINV;
  • Average: 30 to 90% occurrence of CINV;
  • High: > 90% occurrence of CINV. These treatments have been the subject of recommendations. Despite these available treatments, some patients still complain of vomiting, or more frequently nausea and loss of appetite.

Meanwhile, Chinese acupuncture has proven effective on the prevention of CINV as complementary treatment, mainly in the acute phase and to a lesser extent in the delayed phase. The most common points are Pericardium 6 (wrist) treated with conventional acupuncture needles, electro-acupuncture or acupressure.

Auriculotherapy (ear acupuncture) has proven effective on nausea of pregnancy and postoperative nausea, but, to our knowledge, there are no studies published on the effect of auriculotherapy on CINV.

These complementary treatments have virtually no side effects. In our institution, a simple treatment of acupuncture (2 points Pericardium 6 treated) and auriculotherapy (2 auricular point treated) is regularly use in patients who present CINV despite preventive treatment and most of them are relieved.

The investigators propose a clinical trial in this population to assess symptoms improvement in patients presenting CINV after their first administration of chemotherapy despite adapted preventive treatment. Experimental treatment with semi-permanent needles takes place during administration of the second session of chemotherapy. CINV are evaluated through the (MAT) score that measures the frequency and intensity of nausea and vomiting in the 24 hours following the session and during the 4 days after administration Chemotherapy.

Multinational Association of Supportive Care in Cancer Antiemesis Tool (MASCC), Http://www.MASCC.org/.

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

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

  • out-patient chemotherapy
  • treated nausea vomiting induced by chemotherapy (NVIC)

排除标准

  • prior treatment with acupuncture and or auriculotherapy for NVIC
  • no conventional treatment for NVIC like phytotherapy and homeopathy
  • radiotherapy (five days before and 5 days after chemotherapy)
  • MRI in the five days after first visit

结局指标

主要结局

Digital Scale for nausea

时间窗: 1 day

Digital Scale for nausea (H24 MAT score)

次要结局

未报告次要终点

研究者

发起方
Hopital Foch
申办方类型
Other
责任方
Sponsor

研究点 (7)

Loading locations...

相似试验