Electro-acupunctureNCT03061396
The Comparative Study on the Efficacy and Safety of Single Acupoint and Matching Acupoints
A study testing Matching points PC6+CV12 and Single points PC6 in people with Electro-acupuncture and Chemotherapy-induced Nausea and Vomiting, run by Tianjin University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The purpose of this study is to clarify whether the matching acupoints are more effective than a single point by electro-acupuncture in the management of chemotherapy-induced nausea and vomiting. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Electro-acupuncture, Chemotherapy-induced Nausea and Vomiting
- What is being tested?
- Matching points PC6+CV12 and Single points PC6
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteChina
- Study dates
- 17 Feb 2017to 28 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be diagnosed as cancer and need to accept chemotherapy
- The score of Karnofsky ≥70
- Patients of either gender and age 18 years to 80 years
- Patients receiving chemotherapy both outpatients and inpatients
- Patients receiving chemotherapy regime with high risk of causing vomiting: cisplatin ≥60 mg/m2, or joint chemotherapy regime of Anthracyclines (Adriamycin≥ 40 mg/ m2 or epirubicin≥60 mg/m2), Dacarbazine or Carboplatin（area under the curve greater than 5mg/ml/min）
- Life expectancy > 6 months
Who cannot join
- To receive radiotherapy and chemotherapy
- Gastrointestinal tumors
- Patients with serious liver disease or abnormal hepatorenal function (Aspartate Aminotransferase, Alanine Aminotransferase , and Total Bilirubin are 3 times more than normal, blood urea nitrogen and Cr are 2 times more than normal)
- Presence of cardiac pacemaker
- Inflammatory skin reaction
- Nausea and/or vomiting resulting from opioids or metabolic imbalance (electrolytic disturbances)
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- Patients unable to provide self-care or communication
- Nausea and/or vomiting resulting from mechanical risk factors (i.e.,intestinal obstruction)
- Patients with brain metastases or symptoms of intracranial hypertension
- Nausea and/or vomiting resulting from other diseases(i.e.,sympathetic cervical dispositions, Meniere's syndrome)
- Women in pregnant and lactating period
- Refusal to sign informed consent, rejection of randomization into intervention groups.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin University of TCM
Tianjin, Tianjin Municipality, 300193
Guo Yi, Doc, 13920921016, tjutcmacupuncture@163.com
About this study
Official title: The Different Effectiveness of Single Acupoint vs Matching Acupoints in Chemotherapy-induced Nausea and Vomiting：A Multicenter, Randomized, Controlled Clinical Trial
The purpose of this study is to clarify whether the matching acupoints are more effective than a single point by electro-acupuncture in the management of chemotherapy-induced nausea and vomiting.
- Being tested
- Matching points PC6+CV12, Single points PC6
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Matching points PC6+CV12Other
Choose both Neiguan(PC6) and Zhongwan point(CV12).The needles are connected through a electro-acupuncture apparatus, the positive poles are linked to the needle, and the reference poles are located near the acupoint about 1cm with a electrode.Frequency is 2/10 hertz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10 milliampere. And plus 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron, Tropisetron，Granisetron or Ondansetron) and dexamethasone.
Single points PC6Other
Choose Neiguan(PC6)of double upper limb.The needles are connected through a electro-acupuncture apparatus, the positive poles are linked to the needle, and the reference poles are located near the acupoint about 1cm with a electrode.Frequency is 2/10 hertz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10 milliampere. And plus 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron, Tropisetron，Granisetron or Ondansetron) and dexamethasone.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture Single point | Experimental | Single point PC6 means there is only one acupoint to be chosen: Neiguan(PC6) Receives: Other: Single points PC6 |
| Electroacupuncture Matching points | Experimental | There are three acupoints to be chosen:Bilateral Neiguan(PC6)and Zhongwan(CV12) Receives: Other: Matching points PC6+CV12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Control rates of Nausea and Vomiting
There is no emetic episodes, no rescue therapy, and no significant nausea from first day of antiemetic therapy to 5th day.
Measured: 6weeks
Complete Response rates of Vomiting
There is no emetic episodes and no rescue therapy on first day of antiemetic therapy and second day to 5th day.
Measured: 6weeks
Nausea and Vomiting visual analogic scale (VAS)
Measured: 6weeks
Secondary outcomes (5)
Tcm Gastro-intestinal evaluation
Measured: 3weeks
the grading of constipation ,diarrhea and decrease in appetite
Number of participants with constipation ,diarrhea and decrease events as assessed by CTCAE v4.0
Measured: 3weeks
Electrogastrogram
Measured: 3weeks
Hospital Anxiety and Depression Scale
Measured: 3weeks
Functional Assessment of Cancer Treatment - General scale4.0
Measured: 3weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start17 Feb 2017
- Primary completion28 Apr 2018 (estimated)
- Study completion28 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electro-acupunctureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Basic Research Program, China, West China Hospital, Tianjin Medical University Cancer Institute and Hospital, Gansu Provincial Cancer Hospital, Henan Provincial People's Hospital
- Responsible party
- Principal investigator, Yi Guo, Tianjin University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061396
- Sponsor's protocol ID
- 2014CB543201-03
- Status last verified
- Feb 2018
- First submitted
- 5 Feb 2017
- Last updated
- 9 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Different Effectiveness of Single Acupoint vs Matching Acupoints in Chemotherapy-induced Nausea and Vomiting：A Multicenter, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03061396
- Acronym / sponsor ID
- 2014CB543201-03
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Tianjin University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- National Basic Research Program, China, West China Hospital, Tianjin Medical University Cancer Institute and Hospital, Gansu Provincial Cancer Hospital, Henan Provincial People's Hospital
- Study start
- 17 Feb 2017 (actual)
- Primary completion
- 28 Apr 2018 (estimated)
- Study completion
- 28 May 2018 (estimated)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to clarify whether the matching acupoints are more effective than a single point by electro-acupuncture in the management of chemotherapy-induced nausea and vomiting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture Single point | Experimental | Other: Single points PC6Single point PC6 means there is only one acupoint to be chosen: Neiguan(PC6) |
| Electroacupuncture Matching points | Experimental | Other: Matching points PC6+CV12There are three acupoints to be chosen:Bilateral Neiguan(PC6)and Zhongwan(CV12) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be diagnosed as cancer and need to accept chemotherapy
- The score of Karnofsky ≥70
- Patients of either gender and age 18 years to 80 years
- Patients receiving chemotherapy both outpatients and inpatients
- Patients receiving chemotherapy regime with high risk of causing vomiting: cisplatin ≥60 mg/m2, or joint chemotherapy regime of Anthracyclines (Adriamycin≥ 40 mg/ m2 or epirubicin≥60 mg/m2), Dacarbazine or Carboplatin（area under the curve greater than 5mg/ml/min）
Key exclusion criteria (12 listed)
- To receive radiotherapy and chemotherapy
- Gastrointestinal tumors
- Patients with serious liver disease or abnormal hepatorenal function (Aspartate Aminotransferase, Alanine Aminotransferase , and Total Bilirubin are 3 times more than normal, blood urea nitrogen and Cr are 2 times more than normal)
- Presence of cardiac pacemaker
- Inflammatory skin reaction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Matching points PC6+CV12Choose both Neiguan(PC6) and Zhongwan point(CV12).The needles are connected through a electro-acupuncture apparatus, the positive poles are linked to the needle, and the reference poles are located near the acupoint about 1cm with a electrode.Frequency is 2/10 hertz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10 milliampere. And plus 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron, Tropisetron，Granisetron or Ondansetron) and dexamethasone. | Other | Electroacupuncture Matching points |
| Single points PC6Choose Neiguan(PC6)of double upper limb.The needles are connected through a electro-acupuncture apparatus, the positive poles are linked to the needle, and the reference poles are located near the acupoint about 1cm with a electrode.Frequency is 2/10 hertz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10 milliampere. And plus 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron, Tropisetron，Granisetron or Ondansetron) and dexamethasone. | Other | Electroacupuncture Single point |
Primary outcome
Complete Control rates of Nausea and Vomiting
Time frame: 6weeks
There is no emetic episodes, no rescue therapy, and no significant nausea from first day of antiemetic therapy to 5th day.
Complete Response rates of Vomiting
Time frame: 6weeks
There is no emetic episodes and no rescue therapy on first day of antiemetic therapy and second day to 5th day.
Nausea and Vomiting visual analogic scale (VAS)
Time frame: 6weeks
5 secondary outcomes
Tcm Gastro-intestinal evaluation
Time frame: 3weeks
the grading of constipation ,diarrhea and decrease in appetite
Time frame: 3weeks
Electrogastrogram
Time frame: 3weeks
Hospital Anxiety and Depression Scale
Time frame: 3weeks
Functional Assessment of Cancer Treatment - General scale4.0
Time frame: 3weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Matching points PC6+CV12 and Single points PC6 in people with Electro-acupuncture and Chemotherapy-induced Nausea and Vomiting, run by Tianjin University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Control rates of Nausea and Vomiting (time frame: 6weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2018.