- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02469493
The Effect and Mechanism of Electroacupuncture on Acute Chemotherapy-induced Nausea and Vomiting
June 18, 2015 updated by: 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).
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
160
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jin, Doctor
- Email: king-jlm@163.com
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710032
- Recruiting
- Xijing Hospital
-
Contact:
- Yang
- Phone Number: 86(029)-84775343
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
|
Experimental: 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.
|
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 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.
|
No Intervention: Waitinglist control
In this group, patients received no electroacupuncture
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The scores of Rhodes Index of Nausea, Vomiting and Retching.
Time Frame: 24 hours
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Content of 5-hiaa in urine
Time Frame: 12 hours
|
12 hours
|
Heart Rate Variability
Time Frame: 1 hour
|
1 hour
|
Tachygastria percentage
Time Frame: 1 hour
|
1 hour
|
Dosage of antiemetic drugs
Time Frame: 24 hours
|
24 hours
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Neuroimaging data
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Anticipated)
July 1, 2017
Study Registration Dates
First Submitted
June 8, 2015
First Submitted That Met QC Criteria
June 10, 2015
First Posted (Estimate)
June 11, 2015
Study Record Updates
Last Update Posted (Estimate)
June 22, 2015
Last Update Submitted That Met QC Criteria
June 18, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014CB543203
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lung Neoplasms
-
UNC Lineberger Comprehensive Cancer CenterSivan Innovation Ltd.CompletedLung Cancer | Neoplasms, Lung | Pulmonary Neoplasms | Neoplasms, Pulmonary | Pulmonary Cancer | Cancer of LungUnited States
-
Baptist Health South FloridaWithdrawnLung Cancer | Lung TumorUnited States
-
Oliver JonasMassachusetts General HospitalCompletedLung Cancer | Lung TumorUnited States
-
C. R. BardCompleted
-
Portsmouth Hospitals NHS TrustCompletedLung Cancer | Interstitial Lung DiseaseUnited Kingdom
-
Azienda Sanitaria-Universitaria Integrata di UdineRecruitingLung Diseases | Lung Cancer | Lung Adenocarcinoma | Lung Transplant Rejection | Lung; Node | Lung TBItaly
-
Point TherapeuticsTerminatedCarcinoma, Non-Small-Cell Lung | Lung Cancer | Neoplasms, Lung | Neoplasms, PulmonaryUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)CompletedLung Carcinoma | Lung Neoplasm | Malignant Lung NeoplasmUnited States
-
Keimyung University Dongsan Medical CenterCompletedLung Cancer | Lung Diseases, Interstitial
-
University of UtahRecruitingLung Cancer | Lung Neoplasms/DiagnosisUnited States
Clinical Trials on acupuncture (Huatuo)
-
Guang'anmen Hospital of China Academy of Chinese...Ministry of Science and Technology of the People´s Republic of ChinaCompleted
-
Xijing HospitalAir Force Military Medical University, ChinaUnknownRheumatic Valve DiseaseChina
-
Huashan HospitalGuangzhou Baiyunshan Qixing Pharmarceutical Co LtdUnknown
-
Xiyuan Hospital of China Academy of Chinese Medical...Recruiting
-
Guang'anmen Hospital of China Academy of Chinese...Ministry of Science and Technology of the People´s Republic of ChinaCompletedUrinary Stress IncontinenceChina
-
Shanghai Yueyang Integrated Medicine HospitalCompletedStress Urinary Incontinence in WomenChina
-
Federal University of São PauloCompleted
-
University of ZurichCharite University, Berlin, Germany; First Teaching Hospital of Tianjin University...CompletedExperimental Dental PainSwitzerland
-
University of SkövdeCompleted
-
National Research Centre of Complementary and Alternative...Norwegian Acupuncture CollegeUnknown