ACTIN: Acupuncture for Chemical Therapy Induced Nausea and Vomiting: a Cross-over Trail
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: A (Acupuncturist 1) Manual acupuncture implemented by acupuncturist 1 (clinical experience >15 years) |
Procedure: Manual acupuncture implemented by acupuncturist 1
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.
Other Names:
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| Active Comparator: B (Acupuncturist 2) Manual acupuncture implemented by acupuncturist 2 (clinical experience < 5 years) |
Procedure: Manual acupuncture implemented by acupuncturist 2
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- NCI nausea and vomiting rating scale [day1-8 on each study period]
Secondary Outcome Measures
- 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) [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]
Other Outcome Measures
- patient communication satisfaction scale [day 5 on each study period]
- Acupuncture related adverse events [day 1-5 each study period]
faintng during acupuncture treatment, sticking of needle, bleeding in the needling hole, broken needles
- Adverse events (not acupuncture treatment specified) [day 1-5 each study period]
- Needling manipulation parameters [day 1-5 each study period]
Displacement Frequency (Hz) Displacement Amplitude (pk-pk) Rotation Frequency (Hz) Rotation Amplitude (pk-pk)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Confirmed diagnosis of cancer
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Must receive cancer chemotherapy containing cisplatin
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Able to complete at least two continuous chemotherapy treatment cycles
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Karnofsky performance status grade ≥60
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Must use 5-TH receptor antagonists as an antiemetic drug in the chemotherapy duration
Exclusion Criteria:
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Concurrent neoplasms or illness that induces nausea independent of chemotherapy
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Receiving radiotherapy
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Received acupuncture treatments for other conditions less than 4 weeks before chemotherapy treatment
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Severe infection
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Severe heart, liver, kidney and brain diseases
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Unconsciousness
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Psychosis
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Language barriers
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Cardiac pacemaker
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Radiotherapy or hormone therapy during chemotherapy treatments
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Xiyuan Hospital, China Academy of Chinese Medical Sciences | Beijing | China | 100091 |
Sponsors and Collaborators
- Beijing University of Chinese Medicine
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
Investigators
- Principal Investigator: Yutong Fei, MD, Beijing University of Chinese Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EBM@BUCM-1
- Z111107054511086