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| Name | Class |
|---|---|
| Beijing Shijitan Hospital, Capital Medical University | OTHER |
| Beijing Friendship Hospital | OTHER |
| Beijing Municipal Administration of Hospitals | OTHER_GOV |
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Nausea and vomiting are the most common symptoms experienced by cancer patients after chemotherapy. Some patients have to endure such unpleasant symptoms even after using of antiemetic or anti-vomiting medications.The purpose of this study is to assess the therapeutic effects and safety of acupuncture for chemotherapy-induced nausea and vomiting on patients with malignancy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum acupuncture and medicine | Experimental | Participants will receive acupuncture therapy 1 hour prior to chemotherapy administration ，6 hours after chemotherapy administration，and once acupuncture therapy on the following day2,3,4,5. The stimulation points are RN12,LR13(bilaterally), RN6, ST25(bilaterally), PC6(bilaterally), ST36(bilaterally). The acupuncture needle in ST36 and auxiliary point will be connected to form a circuit containing a SDZ-V stimulator for 30 min with a frequency of 2/100 Hz.They will receive 8mg Ondansetron Intravenously twice a day during the chemotherapy administration period (5 days in total). |
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| Sham acupuncture and medicine | Sham Comparator | Participants will receive minimal acupuncture therapy at the same time as the intervention group .The stimulation points are not belong to traditional Chinese medicine.They will receive 8mg Ondansetron Intravenously twice a day during the chemotherapy administration period (5 days in total). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verum acupuncture and medicine | Other | Participants will receive acupuncture therapy 1 hour prior to chemotherapy administration ，6 hours after chemotherapy administration，and once acupuncture therapy on the following day2,3,4,5. The stimulation points are RN12,LR13(bilaterally), RN6, ST25(bilaterally), PC6(bilaterally), ST36(bilaterally). The acupuncture needle in ST36 and auxiliary point will be connected to form a circuit containing a SDZ-V stimulator for 30 min with a frequency of 2/100 Hz. They will receive 8mg Ondansetron Intravenously twice a day during the chemotherapy administration period (5 days in total). |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in severity of nausea and vomiting at 21 days | The severity of nausea and vomiting will be assessed by the Common Terminology Criteria for Adverse Events (CTCAE) | It will be assessed at baseline,day1, day 2, day 3, day 7(±1)，day 10(±1), day 14(±1), day 21(±1).Patients have a daily questionnaire about nausea and vomiting during chemotherapy to record their feelings |
| Measure | Description | Time Frame |
|---|---|---|
| TCM symptoms scale | to evaluate TCM syndrome | It will be assessed at baseline, day3, day7(±1), day14(±1), day21(±1).Patients will be accessed with questionaire by doctors. |
| ECOG score scale | to evaluate physical condition of patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaomin Wang, Doctor | Contact | +86(010)52176508 | wangxiaomin_bhtcm@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaomin Wang, Doctor | Beijing Hospital of Traditional Chinese Medicine | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28427442 | Derived | Li QW, Yu MW, Yang GW, Wang XM, Wang H, Zhang CX, Xue N, Xu WR, Fu Q, Yang Z, Yang L. Effect of acupuncture in prevention and treatment of chemotherapy-induced nausea and vomiting in patients with advanced cancer: study protocol for a randomized controlled trial. Trials. 2017 Apr 20;18(1):185. doi: 10.1186/s13063-017-1927-2. |
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| ID | Term |
|---|---|
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
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|
| Sham acupuncture and medicine | Other | Participants will receive minimal acupuncture therapy at the same time as the intervention group .The stimulation points are not belong to traditional Chinese medicine.They will receive 8mg Ondansetron Intravenously twice a day during the chemotherapy administration period (5 days in total). |
|
| It will be assessed at baseline, day3, day7(±1), day14(±1), day21(±1).Patients will be accessed with questionaire by doctors. |
| HADS | a questionnaire to access the anxiety levels of patients | It will be assessed at baseline, day3, day7(±1), day14(±1), day21(±1).Patients will be accessed with questionaire by doctors. |