The Effect and Mechanism of Electroacupuncture on Acute Chemotherapy-induced Nausea and Vomiting

Study Overview
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Brief Summary
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The purpose of this study is to compare the preventive effect of electroacupuncture and sham acupuncture on acute chemotherapy-induced nausea and vomiting and then investigate its potential mechanism by using functional Magnetic Resonance Imaging (fMRI).

Conditions
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Lung Neoplasms

Intervention / Treatment
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* Device: acupuncture (Huatuo)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First diagnosed stage Ⅲ-Ⅳ lung cancer patients on cisplatin chemotherapy; Right-handed and aged 18 to 75 years; Karnosky performance status (KPS) ≥ 70; Life expectancy ≥ 6 months. Exclusion Criteria: Had brain metastases or other concurrent life-threatening diseases; 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture 1<br>In this group, patients separately received twice electroacupuncture at bilateral PC6 acupoint before and after Cisplatin administration on the first day of chemotherapy. | Device: acupuncture (Huatuo)<br>* 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.<br>|
| Experimental: Acupuncture 2<br>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. | Device: acupuncture (Huatuo)<br>* 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.<br>|
| Sham Comparator: Sham acupuncture<br>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. | Device: acupuncture (Huatuo)<br>* 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.<br>|
| No Intervention: Waitinglist control<br>In this group, patients received no electroacupuncture | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The scores of Rhodes Index of Nausea, Vomiting and Retching. |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Content of 5-hiaa in urine |  | 12 hours | 
| Heart Rate Variability |  | 1 hour | 
| Tachygastria percentage |  | 1 hour | 
| Dosage of antiemetic drugs |  | 24 hours |