to Evaluate the Effectiveness of Acupucnture in the Management of Chemotherapy-induced Nausea and VomitingNCT02195908
The Different Effectiveness of Single Acupoint（PC6 or CV12) vs Matching Acupoints(PC6 and CV12) in Chemotherapy-induced Nausea and Vomiting
A study testing single point Neiguan(PC6) plus antiemetic drug, single point Zhongwan(CV12) plus antiemetic drug and matching points Neiguan(PC6) and Zhongwan(CV12) plus antiemetic drug in people with to Evaluate the Effectiveness of Acupucnture in the Management of 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
- to Evaluate the Effectiveness of Acupucnture in the Management of Chemotherapy-induced Nausea and Vomiting
- What is being tested?
- single point Neiguan(PC6) plus antiemetic drug, single point Zhongwan(CV12) plus antiemetic drug and matching points Neiguan(PC6) and Zhongwan(CV12) plus antiemetic drug
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Aug 2014to Oct 2015
- 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 older than 18 years
- Patients receiving chemotherapy both outpatients and inpatients
- Patients receiving chemotherapy either the first or multiple cycle, but the patient will be taken in only one time
- To receive chemotherapy containing cisplatin(DDP≥75mg/m2) or joint chemotherapy programmes of Anthracyclines(Adriamycin≥40mg/m2 or epirubicin≥60mg/m2)
- Life expectancy≥ 6 months
- Willing to participate in the study and be randomized into one of the four study groups.
Who cannot join
- To receive radiotherapy and chemotherapy
- Gastrointestinal tumors
- Patients with serious liver disease or abnormal hepatorenal function (AST,ACT, and TBIL are 3 times more than normal, BUN and Cr are 2 times more than normal)
- Presence of cardiac pacemaker
- Active skin infection
- Nausea and/or vomiting resulting from opioids or metabolic imbalance (electrolyte 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)
- Brain metastases
- Women in pregnant and lactating period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparative Study on the Effectiveness of Single Acupoint and Matching Acupoints.
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
- single point Neiguan(PC6) plus antiemetic drug, single point Zhongwan(CV12) plus antiemetic drug, matching points Neiguan(PC6) and Zhongwan(CV12) plus antiemetic drug, only antiemetic drug
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single point Neiguan(PC6) plus antiemetic drugOther
single point Zhongwan(CV12) plus antiemetic drugOther
matching points Neiguan(PC6) and Zhongwan(CV12) plus antiemetic drugOther
only antiemetic drugDrug
| Study group | Role | What they receive |
|---|---|---|
| Single point PC6 | Experimental | choose single point: Neiguan(PC6).Neiguan(PC6): On the anterior aspect of the forearm,between the tendons of the palmaris longus and the flexor carpi radialis, 2 B-cun proximal to the palmar wrist crease.Manipulating until achieving a "de Qi" sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA. The operation lasts for 30 min. The treatment is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days. Receives: Other: single point Neiguan(PC6) plus antiemetic drug |
| Single point CV12 | Experimental | choose another single point Zhongwan（CV12）. Zhongwan(CV12): On the upper abdomen, 4 B-cun superior to the centre of the umbilicus, on the anterior median line. Manipulating until achieving a "de Qi" sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatment is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days. Receives: Other: single point Zhongwan(CV12) plus antiemetic drug |
| Matching points PC6+CV12 | Experimental | Choose both Neiguan point(PC6) and Zhongwan point(CV12). Manipulating until achieving a "de Qi" sensation, then 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 paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA. The operation lasts for 30 min. The treatment is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days. Receives: Other: matching points Neiguan(PC6) and Zhongwan(CV12) plus antiemetic drug |
| only antiemetic | Active comparator | The control group will receive standard antiemetic alone. Standard antiemetic for all groups is based on American Society of Clinical Oncology clinical practice guideline. 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron, Tropisetron) and dexamethasone are supplied from the first day of chemotherapy, and lasting for 3-5 days. Receives: Drug: only antiemetic drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
the frequency of Nausea and Vomiting
Measured: 6days
Secondary outcomes (4)
the grading of constipation and diarrhea
Measured: 3 weeks
electrogastrogram
Measured: 3 weeks
the assessment of quality of life
Measured: 3 weeks
the assessment of Anxiety and Depression
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionJul 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for to Evaluate the Effectiveness of Acupucnture in the Management of Chemotherapy-induced Nausea and VomitingStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Basic Research Program, China
- Responsible party
- Principal investigator, Yi Guo, Tianjin University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02195908
- Sponsor's protocol ID
- 2014CB543201-01
- Status last verified
- Oct 2020
- First submitted
- 17 Jul 2014
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen B, Hu SX, Liu BH, Zhao TY, Li B, Liu Y, Li MY, Pan XF, Guo YM, Chen ZL, Guo Y. Efficacy and safety of electroacupuncture with different acupoints for chemotherapy-induced nausea and vomiting: study protocol for a randomized controlled trial. Trials. 2015 May 12;16:212. doi: 10.1186/s13063-015-0734-x.
PubMed 25963295
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparative Study on the Effectiveness of Single Acupoint and Matching Acupoints.
- ClinicalTrials.gov ID
- NCT02195908
- Acronym / sponsor ID
- 2014CB543201-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Tianjin University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- National Basic Research Program, China
- Study start
- Aug 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 21 Jul 2014 (estimated)
- 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
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single point PC6 | Experimental | Other: single point Neiguan(PC6) plus antiemetic drugchoose single point: Neiguan(PC6).Neiguan(PC6): On the anterior aspect of the forearm,between the tendons of the palmaris longus and the flexor carpi radialis, 2 B-cun proximal to the palmar wrist crease.Manipulating until achieving a "de Qi" sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA. The operation lasts for 30 min. The treatment is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days. |
| Single point CV12 | Experimental | Other: single point Zhongwan(CV12) plus antiemetic drugchoose another single point Zhongwan（CV12）. Zhongwan(CV12): On the upper abdomen, 4 B-cun superior to the centre of the umbilicus, on the anterior median line. Manipulating until achieving a "de Qi" sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA.The operation lasts for 30 min. The treatment is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days. |
| Matching points PC6+CV12 | Experimental | Other: matching points Neiguan(PC6) and Zhongwan(CV12) plus antiemetic drugChoose both Neiguan point(PC6) and Zhongwan point(CV12). Manipulating until achieving a "de Qi" sensation, then 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 paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA. The operation lasts for 30 min. The treatment is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days. |
| only antiemetic | Active comparator | Drug: only antiemetic drugThe control group will receive standard antiemetic alone. Standard antiemetic for all groups is based on American Society of Clinical Oncology clinical practice guideline. 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron, Tropisetron) and dexamethasone are supplied from the first day of chemotherapy, and lasting for 3-5 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be diagnosed as cancer and need to accept chemotherapy.
- The score of Karnofsky ≥70
- Patients of either gender and older than 18 years
- Patients receiving chemotherapy both outpatients and inpatients
- Patients receiving chemotherapy either the first or multiple cycle, but the patient will be taken in only one time
Key exclusion criteria (10 listed)
- To receive radiotherapy and chemotherapy
- Gastrointestinal tumors
- Patients with serious liver disease or abnormal hepatorenal function (AST,ACT, and TBIL are 3 times more than normal, BUN and Cr are 2 times more than normal)
- Presence of cardiac pacemaker
- Active skin infection
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 |
|---|---|---|
| single point Neiguan(PC6) plus antiemetic drug | Other | Single point PC6 |
| single point Zhongwan(CV12) plus antiemetic drug | Other | Single point CV12 |
| matching points Neiguan(PC6) and Zhongwan(CV12) plus antiemetic drug | Other | Matching points PC6+CV12 |
| only antiemetic drug | Drug | only antiemetic |
Primary outcome
the frequency of Nausea and Vomiting
Time frame: 6days
4 secondary outcomes
the grading of constipation and diarrhea
Time frame: 3 weeks
electrogastrogram
Time frame: 3 weeks
the assessment of quality of life
Time frame: 3 weeks
the assessment of Anxiety and Depression
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Derived from this study: PubMed 25963295Chen B, Hu SX, Liu BH, Zhao TY, Li B, Liu Y, Li MY, Pan XF, Guo YM, Chen ZL, Guo Y. Efficacy and safety of electroacupuncture with different acupoints for chemotherapy-induced nausea and vomiting: study protocol for a randomized controlled trial. Trials. 2015 May 12;16:212. doi: 10.1186/s13063-015-0734-x.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single point Neiguan(PC6) plus antiemetic drug, single point Zhongwan(CV12) plus antiemetic drug and matching points Neiguan(PC6) and Zhongwan(CV12) plus antiemetic drug in people with to Evaluate the Effectiveness of Acupucnture in the Management of 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 8 inclusion and 10 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: finished, as of the sponsor's last update on 8 Oct 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the frequency of Nausea and Vomiting (time frame: 6days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02195908, which also lists 1 linked publication.
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 8 Oct 2020.