Impact of Acupuncturist Expertise on Clinical Effectiveness for Chemotherapy Induced Nausea and Vomiting in Cancer Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 3
- 主要终点
- NCI nausea and vomiting rating scale
研究概览
简要总结
This is an expertise-based randomized controlled trial. The hypothesis of this study is that the differences in expertise of acupuncturist may impact clinical effect. In this study, patients will be randomized to 4 group, receiving the treatment from senior acupuncturist, junior acupuncturist, junior acupuncturist by only acupuncture Neiguan(P6), or not receive the acupuncture. All patients receive the basic cisplatin chemotherapy. The duration of treatment is from the first day receiving cisplatin until two days after cisplatin on each group. NCI and Rhode scale will be used to measure the control of nausea and vomiting.
详细描述
This is an expertise-based randomized controlled trial. The hypothesis of this study is that the differences in expertise of acupuncturist may impact clinical effect. In this study, 102 patients will be randomly divided into 4 groups which separately receiving the treatment from senior acupuncturist(clinical experience> 15 years, considered in this trial as highly expertised), junior acupuncturist(clinical experience< 5 years, considered in this trial as lower expertised), junior acupuncturist only acupuncture Neiguan(P6), or not receiving the acupuncture. All participants receive the cisplatin-based chemotherapy and 5-HT3 as antiemetic treatment will be included. Acupuncture treatments are given once daily, the duration of treatment is from the first day receiving cisplatin until two days after cisplatin. NCI and Rhode scale will be used to measure the control of nausea and vomiting. only outcome assessors are blinded. Generalized estimating equations will be used to compare the effects among groups.
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
- Single (Outcomes Assessor)
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
- •Confirmed diagnosis of cancer
- •Must receive cancer chemotherapy containing cisplatin
- •Use 5-TH receptor antagonists as an antiemetic drug in the chemotherapy duration
排除标准
- •Concurrent neoplasms or illness that induces nausea independent of chemotherapy
- •Received acupuncture treatments for other conditions less than 4 weeks before chemotherapy treatment
- •Severe infection
- •Severe heart, liver, kidney and brain diseases
- •Cardiac pacemaker
- •Radiotherapy or hormone therapy during chemotherapy treatments
研究组 & 干预措施
A(senior acupuncturists)
Manual acupuncture implemented by senior acupuncturists (clinical experience >15 years)
干预措施: Manual acupuncture implemented by senior acupuncturists (Procedure)
B(junior acupuncturists)
Manual acupuncture implemented by junior acupuncturists (clinical experience <5 years)
干预措施: Manual acupuncture implemented by junior acupuncturists (Procedure)
C(P6 points)
Manual acupuncture on P6 points by junior acupuncturists (clinical experience <5 years)
干预措施: Manual acupuncture on P6 point (Procedure)
D(no acupuncture)
No acupuncture treatment
结局指标
主要结局
NCI nausea and vomiting rating scale
时间窗: From the first day receiving cisplatin until two days after cisplatin in each group
Rhodes Scale
时间窗: From the first day receiving cisplatin until two days after cisplatin in each group
次要结局
- Patients' confidence towards acupuncture treatment (a single direct question with five levels of alternatives)(The first day receiving cisplatin and the second day after cisplatin)
- Consumption of additional antiemetic(From the first day receiving cisplatin until two days after cisplatin)
- Global assessment on effectiveness by patients (a single direct question with five levels of alternatives)(The second day after cisplatin)
研究者
Yutong Fei
Associate research fellow
Beijing University of Chinese Medicine