Acupuncture for Chemical Therapy Induced Nausea and Vomiting

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact of Acupuncturist Expertise on Clinical Effectiveness for Chemotherapy Induced Nausea and Vomiting in Cancer Patients: a Randomized Controlled Trial

Conditions
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Chemotherapy-induced Nausea and Vomiting

Intervention / Treatment
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* Procedure: Manual acupuncture implemented by senior acupuncturists
* Procedure: Manual acupuncture implemented by junior acupuncturists
* Procedure: Manual acupuncture on P6 point


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of cancer Must receive cancer chemotherapy containing cisplatin Use 5-TH receptor antagonists as an antiemetic drug in the chemotherapy duration Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A(senior acupuncturists)<br>Manual acupuncture implemented by senior acupuncturists (clinical experience >15 years) | Procedure: Manual acupuncture implemented by senior acupuncturists<br>* Manual acupuncture once per day. No limitation on points, manipulations and time per session. Senior acupuncturists have to have more than 15 years of acupuncture clinical practice experience.<br>* Other names: Traditional acupuncture;|
| Active Comparator: B(junior acupuncturists)<br>Manual acupuncture implemented by junior acupuncturists (clinical experience <5 years) | Procedure: Manual acupuncture implemented by junior acupuncturists<br>* Manual acupuncture once per day. No limitation on points, manipulations and time per session. Junior acupuncturists have to have less than 5 years of acupuncture clinical practice experience.<br>* Other names: Traditional acupuncture;|
| Active Comparator: C(P6 points)<br>Manual acupuncture on P6 points by junior acupuncturists (clinical experience <5 years) | Procedure: Manual acupuncture on P6 point<br>* Manual acupuncture implemented by junior acupuncturists once per day. P6 point, bilaterally, should achieve deqi sensation by even manipulations. Junior acupuncturists have to have less than 5 years of acupuncture clinical practice experience.<br>* Other names: Traditional acupuncture;|
| No Intervention: D(no acupuncture)<br>No acupuncture treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NCI nausea and vomiting rating scale |  | From the first day receiving cisplatin until two days after cisplatin in each group | 
| Rhodes Scale |  | From the first day receiving cisplatin until two days after cisplatin in each group | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global assessment on effectiveness by patients (a single direct question with five levels of alternatives) |  | The second day after cisplatin | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, Expertise-based randomized controlled trial, Nausea, Vomiting, Cancer