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| ID | Type | Description | Link |
|---|---|---|---|
| 30901929 | Other Grant/Funding Number | National Natural Science |
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| Name | Class |
|---|---|
| Dongzhimen Hospital, Beijing | OTHER |
| Guang'anmen Hospital of China Academy of Chinese Medical Sciences | OTHER |
| Xiyuan Hospital of China Academy of Chinese Medical Sciences | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A(senior acupuncturists) | Active Comparator | Manual acupuncture implemented by senior acupuncturists (clinical experience >15 years) |
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| B(junior acupuncturists) | Active Comparator | Manual acupuncture implemented by junior acupuncturists (clinical experience <5 years) |
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| C(P6 points) | Active Comparator | Manual acupuncture on P6 points by junior acupuncturists (clinical experience <5 years) |
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| D(no acupuncture) | No Intervention | No acupuncture treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual acupuncture implemented by senior acupuncturists | Procedure | 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. |
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Acupuncture related adverse events | From the first day receiving cisplatin until two days after cisplatin | |
| Adverse events | From the first day receiving cisplatin until two days after cisplatin |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongzhimen Hospital, Beijing University of Chinese medicine | Beijing | Beijing Municipality | 100007 | China | ||
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| ID | Term |
|---|---|
| D014839 | Vomiting |
| D009325 | Nausea |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Manual acupuncture implemented by junior acupuncturists | Procedure | 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. |
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| Manual acupuncture on P6 point | Procedure | 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. |
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| 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 |
| Guanganmen Hospital,China Academy of Chinese Medical Sciences |
| Beijing |
| Beijing Municipality |
| 100053 |
| China |
| Xiyuan Hospital, China Academy of Chinese Medical Sciences | Beijing | 100091 | China |