The Effect and Mechanism of Electroacupuncture on Acute Chemotherapy-induced Nausea and Vomiting
18 juni 2015 uppdaterad av: Wei Qin, Xidian University
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).
Studieöversikt
Studietyp
Interventionell
Inskrivning (Förväntat)
160
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Shaanxi
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Xi'an, Shaanxi, Kina, 710032
- Rekrytering
- Xijing Hospital
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Kontakt:
- Yang
- Telefonnummer: 86(029)-84775343
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
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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.
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Experimentell: 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.
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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.
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Sham Comparator: 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.
|
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.
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Inget ingripande: Waitinglist control
In this group, patients received no electroacupuncture
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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The scores of Rhodes Index of Nausea, Vomiting and Retching.
Tidsram: 24 hours
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24 hours
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Content of 5-hiaa in urine
Tidsram: 12 hours
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12 hours
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Heart Rate Variability
Tidsram: 1 hour
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1 hour
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Tachygastria percentage
Tidsram: 1 hour
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1 hour
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Dosage of antiemetic drugs
Tidsram: 24 hours
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24 hours
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Andra resultatmått
Resultatmått |
Tidsram |
|---|---|
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Neuroimaging data
Tidsram: 24 hours
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24 hours
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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2015
Primärt slutförande (Förväntat)
1 juli 2017
Studieregistreringsdatum
Först inskickad
8 juni 2015
Först inskickad som uppfyllde QC-kriterierna
10 juni 2015
Första postat (Uppskatta)
11 juni 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
22 juni 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 juni 2015
Senast verifierad
1 juni 2015
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2014CB543203
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .