The Effect and Mechanism of Electroacupuncture on Acute Chemotherapy-induced Nausea and Vomiting
NCT ID: NCT02469493
Last Updated: 2015-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
160 participants
INTERVENTIONAL
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Acupuncture 1
In this group, patients separately received twice electroacupuncture at bilateral PC6 acupoint before and after Cisplatin administration on the first day of chemotherapy.
acupuncture (Huatuo)
The needles used were Huatuo brand (Suzhou, China) sterile disposable stainless steel filiform; needles sized 0.25\*25 mm. After disinfection, needles were inserted 0.5 to 0.8 inches into the skin and were manipulated manually to obtain Deqi. An electric stimulator (Huatuo SDZ-V, Suzhou, China) was connected to the needles and delivered a constant-current, 0.2-ms, density-wave, stimulus of 2 to 10-Hz frequency, level of intensity was as much as tolerable, but not painful to the subjects. The needles were left for 30 minutes and then removed.
Acupuncture 2
In this group, patients separately received twice electroacupuncture at bilateral PC6 and RN12 acupoints before and after Cisplatin administration on the first day of chemotherapy.
acupuncture (Huatuo)
The needles used were Huatuo brand (Suzhou, China) sterile disposable stainless steel filiform; needles sized 0.25\*25 mm. After disinfection, needles were inserted 0.5 to 0.8 inches into the skin and were manipulated manually to obtain Deqi. An electric stimulator (Huatuo SDZ-V, Suzhou, China) was connected to the needles and delivered a constant-current, 0.2-ms, density-wave, stimulus of 2 to 10-Hz frequency, level of intensity was as much as tolerable, but not painful to the subjects. The needles were left for 30 minutes and then removed.
Sham acupuncture
In this group, patients separately received twice electroacupuncture at bilateral nonacupuncture point (S1 located at lateral of flexor carpi radialis, 2 cun above the wrist. S2 located at 3 cun right side of RN12) before and after Cisplatin administration on the first day of chemotherapy.
acupuncture (Huatuo)
The needles used were Huatuo brand (Suzhou, China) sterile disposable stainless steel filiform; needles sized 0.25\*25 mm. After disinfection, needles were inserted 0.5 to 0.8 inches into the skin and were manipulated manually to obtain Deqi. An electric stimulator (Huatuo SDZ-V, Suzhou, China) was connected to the needles and delivered a constant-current, 0.2-ms, density-wave, stimulus of 2 to 10-Hz frequency, level of intensity was as much as tolerable, but not painful to the subjects. The needles were left for 30 minutes and then removed.
Waitinglist control
In this group, patients received no electroacupuncture
No interventions assigned to this group
Interventions
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acupuncture (Huatuo)
The needles used were Huatuo brand (Suzhou, China) sterile disposable stainless steel filiform; needles sized 0.25\*25 mm. After disinfection, needles were inserted 0.5 to 0.8 inches into the skin and were manipulated manually to obtain Deqi. An electric stimulator (Huatuo SDZ-V, Suzhou, China) was connected to the needles and delivered a constant-current, 0.2-ms, density-wave, stimulus of 2 to 10-Hz frequency, level of intensity was as much as tolerable, but not painful to the subjects. The needles were left for 30 minutes and then removed.
Eligibility Criteria
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Inclusion Criteria
* Right-handed and aged 18 to 75 years;
* Karnosky performance status (KPS) ≥ 70;
* Life expectancy ≥ 6 months.
Exclusion Criteria
* Nausea and/or vomiting were present 24h before chemotherapy treatment;
* Suffered from or had a history of gastrointestinal diseases;
* Had a history of head trauma, serious neurological or psychiatric disorders;
* Participating in other clinical trials currently;
* Had any contraindication to exposure to a high magnetic field or receive acupuncture
18 Years
75 Years
ALL
No
Sponsors
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Xidian University
OTHER
Responsible Party
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Wei Qin
Professor
Locations
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Xijing Hospital
Xi'an, Shaanxi, China
Countries
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Central Contacts
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Facility Contacts
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Yang
Role: primary
Other Identifiers
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2014CB543203
Identifier Type: -
Identifier Source: org_study_id
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