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| ID | Type | Description | Link |
|---|---|---|---|
| Z111107054511086 | Other Grant/Funding Number | Beijing Nova Program |
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| Name | Class |
|---|---|
| Xiyuan Hospital of China Academy of Chinese Medical Sciences | OTHER |
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This is a randomized, controlled cross-over trial. The hypothesis of this study is that the differences in manual acupuncture manipulation can impact clinical effect though the acupuncturists follow the same needling regimen. In this study, acupuncturist 1 (clinical experience >15 years) and acupuncturist 2 (<5 years) will give treatments to cancer patients receiving cisplatin chemotherapy (n=36) for at least two continuous cycles, once per day, 5 days per cycle. Acupuncturist 1 determines all the treatment regimens (selection of acupoints and methods of needling manipulation, needle retention time). Randomly, half of the patients will receive treatments from acupuncturist 1 in the first treatment cycle and from acupuncturist 2 in the second cycle; while the other half will be treated in other way round. There is a washout period (21 days) between two cycles. The needling manipulation of two acupuncturists will be measured objectively during treatments. The clinical effect will be measured by the control of vomiting and nausea during and after chemotherapy treatments.
This is a randomized, controlled cross-over trial. The hypothesis of this study is that the differences in manual acupuncture manipulation can impact clinical effect though the acupuncturists follow the same needling regimen. In this study, acupuncturist 1 (clinical experience >15 years) and acupuncturist 2 (<5 years) will give treatments to cancer patients receiving cisplatin chemotherapy (n=36) for at least two continuous cycles, once per day, 5 days per cycle. Acupuncturist 1 determines all the treatment regimens (selection of acupoints and methods of needling manipulation, needle retention time). Randomly, half of the patients will receive treatments from acupuncturist 1 in the first treatment cycle and from acupuncturist 2 in the second cycle; while the other half will be treated in other way round. There is a washout period (21 days) between two cycles. The needling manipulation of two acupuncturists will be measured objectively during treatments. The clinical effect will be measured by the control of vomiting and nausea during and after chemotherapy treatments. The manual manipulation of two acupuncturists will be recorded by device Acusensor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A (Acupuncturist 1) | Active Comparator | Manual acupuncture implemented by acupuncturist 1 (clinical experience >15 years) |
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| B (Acupuncturist 2) | Active Comparator | Manual acupuncture implemented by acupuncturist 2 (clinical experience < 5 years) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual acupuncture implemented by acupuncturist 1 | Procedure | Manual acupuncture once per day. Acupuncture treatment regimens (acupoints, needling methods, needle retention time) were decided by acupuncturist 1 according to the syndrome differentiation of patients. Acupuncturist 1 has to have more than 15 years of acupuncture clinical practice experience. |
| Measure | Description | Time Frame |
|---|---|---|
| NCI nausea and vomiting rating scale | day1-8 on each study period |
| Measure | Description | Time Frame |
|---|---|---|
| Rhodes Scale | day1-5 on each study period | |
| global assessment on effectiveness by patients (VAS) | day 5 on each study period | |
| patients' confidence towards acupuncture treatment(VAS) |
| Measure | Description | Time Frame |
|---|---|---|
| patient communication satisfaction scale | day 5 on each study period | |
| Acupuncture related adverse events | faintng during acupuncture treatment, sticking of needle, bleeding in the needling hole, broken needles |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yutong Fei, MD | Beijing University of Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiyuan Hospital, China Academy of Chinese Medical Sciences | Beijing | 100091 | 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 acupuncturist 2 | Procedure | Manual acupuncture given by acupuncturist 2 once per day. Acupuncture treatment regimens (acupoints, needling methods, needle retention time) were decided by acupuncturist 1 according to the syndrome differentiation of patients. Acupuncturist 2 has to have less than 5 years of acupuncture clinical practice experience. |
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| day 1,5 on each study period |
| global satisfaction for acupuncture treatments | day 5 on each study period |
| Acupuncture Expectancy Scale (AES) | day 1, 3, 5 on each study period |
| day 1-5 each study period |
| Adverse events (not acupuncture treatment specified) | day 1-5 each study period |
| Needling manipulation parameters | Displacement Frequency (Hz) Displacement Amplitude (pk-pk) Rotation Frequency (Hz) Rotation Amplitude (pk-pk) | day 1-5 each study period |