Chemotherapy-induced Nausea and VomitingNCT02195921
Acupuncture for Chemotherapy-Induced Nausea and Vomiting
A study testing single point Zhongwan(CV12) plus antiemetic drug, single point Zusanli(ST36) plus antiemetic drug and Zusanli(ST36)and Zhongwan(CV12) plus antiemetic drug in people with 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 is more effective than a single point by electroacupuncture 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
- Chemotherapy-induced Nausea and Vomiting
- What is being tested?
- single point Zhongwan(CV12) plus antiemetic drug, single point Zusanli(ST36) plus antiemetic drug and Zusanli(ST36)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
- Apr 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 he 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)
Show all 10Show fewer
- 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.
China1 site
Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 301617
About this study
Official title: Acupuncture for Chemotherapy-Induced Nausea and Vomiting: A Randomized Clinical Trial
The purpose of this study is to clarify whether the matching acupoints is more effective than a single point by electroacupuncture in the management of chemotherapy-induced nausea and vomiting .
Read the detailed description
Patients were assigned to Four sessions of electroacupuncture(EA) at the CV12, ST36, CV12+ST36 acupoints or antiemetic therapy over 5 days. primary and secondary outcomes and Adverse Eventswill be assessed.
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Being tested
- single point Zhongwan(CV12) plus antiemetic drug, single point Zusanli(ST36) plus antiemetic drug, Zusanli(ST36)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 Zhongwan(CV12) plus antiemetic drugOther
All participants were supine in the hospital bed. A disposable sterile acupuncture needle (ø 0.30 × 40 mm, Hwato) was inserted vertically at approximately 20-30 mm until "De Qi" (sensation of soreness, numbness, distension, etc. around the acupoint) was reported by the participants. Then, the needle handle was clamped via a metal clip to connect to the positive electrode of the electric acupuncture apparatus (Huatuo, SDZ-V model, Suzhou Medical Appliance). Another reference electrode was placed 1 cm above the CV12 acupoints of the stimulation point, where no acupoints or meridians passed through. A dilatational wave at a frequency of 2/10 Hz and a current intensity at the highest level tolerated by the patient, with a maximum intensity no more than 10 mA, were used to deliver the EA stimulation. People in the intervention groups were offered a standardized 30-minute EA session once daily from the 1st day of the four-day chemotherapy cycle.
single point Zusanli(ST36) plus antiemetic drugOther
A disposable sterile acupuncture needle (ø 0.30 × 40 mm, Hwato) was inserted vertically at approximately 20-30 mm until "De Qi" (sensation of soreness, numbness, distension, etc. around the acupoint) was reported by the participants. Then, the needle handle was clamped via a metal clip to connect to the positive electrode of the electric acupuncture apparatus (Huatuo, SDZ-V model, Suzhou Medical Appliance). Another reference electrode was placed 1cm below ST36 acupoints of the stimulation point, respectively, where no acupoints or meridians passed through. A dilatational wave at a frequency of 2/10 Hz and a current intensity at the highest level tolerated by the patient, with a maximum intensity no more than 10 mA, were used to deliver the EA stimulation. People in the intervention groups were offered a standardized 30-minute EA session once daily from the 1st day of the four-day chemotherapy cycle.
Zusanli(ST36)and Zhongwan(CV12) plus antiemetic drugOther
Stimulating both Zusanli(ST36)and Zhongwan(CV12)
only antiemetic drugDrug
received routine antiemetic treatment
| Study group | Role | What they receive |
|---|---|---|
| Single point CV12 | Experimental | choose 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 treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days. Received routine antiemetic treatment. Receives: Other: single point Zhongwan(CV12) plus antiemetic drug |
| Single point ST36 | Experimental | choose another single point Zusanli（ST36）.Zusanli(ST36):On the anterior aspect of the leg, on the line connecting ST35 with ST41, 3 B-cun inferior to ST35，located on the tibialis anterior muscle..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 treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days. Received routine antiemetic treatment. Receives: Other: single point Zusanli(ST36) plus antiemetic drug |
| ST36+CV12 acupoints | Experimental | Choose both Zusanli(ST36) and Zhongwan（CV12）.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 treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days. Received routine antiemetic treatment. Receives: Other: Zusanli(ST36)and Zhongwan(CV12) plus antiemetic drug |
| only antiemetics | Active comparator | The control group will receive standard antiemetics alone. Standard antiemetics for all groups are 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 chemtherapy,and lasting for 3-5days. If nausea and/or vomiting is persistent and failed to respond to the antiemetic treatment , based on the experience of each clinician, the other advanced 5-HT3 antagonist or a neurokinin 1 antagonist(NK-1) will be chosen. Receives: Drug: only antiemetic drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Nausea
Percentage of participants with nausea was assessed by visual analog scale (VAS) ranging from 0 (no nausea) to 10 (worst nausea). A score of 0 means no nausea for a portion of the patient's assessment.
Measured: 5 days
Number of Times Vomiting Occurs After Chemotherapy
The number of times vomiting occurs after chemotherapy for each participant during 0-120 hours. The evaluator completed daily diaries for each time point.
Measured: 5 days
Rhodes Index of Nausea, Vomiting and Retching
The RINVR scale has 8 items . The scale divides the occurrence of nausea , vomiting , and retching within 12 hours of tumor chemotherapy patients into 5 grades , which are scored from 0 to 4 points . The lower the score , the better . The RINVR scale can be divided into three dimensions : symptom experience time , symptom frequency and symptom severity .
Measured: 5 days
Percentage of Participants With Nausea and Number of Times of Vomiting Occurs After Chemotherapy
Rhodes Index of Nausea, Vomiting and Retching was replaced by percentage of participants with nausea (assessed by VAS) and number of times of vomiting occurs which were recorded in the first and second primary outcome.
Measured: 5 days
Secondary outcomes (4)
Grading of Constipation and Diarrhea
The grading of constipation and diarrhea.We deleted this evaluation method due to weak correlation.
Measured: 5 days
Electrogastrogram
We deleted this evaluation method due to weak correlation.
Measured: 5 days
the Assessment of Quality of Life
Assessed by the Functional Assessment of Cancer Treatment-General (FACT-G) .The FACT-G includes 27 items and is divided among 4 subscales: physical well-being (PWB), functional well-being (FWB), social/family well-being (SWB), and emotional well-being (EWB). The total FACT-G score ranges from 0 to 108 and is calculated by the sum of the subscales, with higher scores indicating greater functional status
Measured: 5 days
the Assessment of Anxiety and Depression
Assessed by Hospital Anxiety and Depression Scale (HADS scale). It includes fourteen items, seven of which assess anxiety and the other seven assess depression (30). The total scores range from 0 to 21 for depression and anxiety, respectively, with higher scores indicating more depression and anxiety.
Measured: 5 days
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 startApr 2015
- Primary completionMar 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Responsible party
- Principal investigator, Yi Guo, Tianjin University of Traditional Chinese Medicine
- Investigators
- Yi Guo, Study director, Tianjin University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02195921
- Sponsor's protocol ID
- 2014CB543201-02
- Status last verified
- Jan 2021
- First submitted
- 17 Jul 2014
- Last updated
- 11 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Chen B, Guo Y, Zhao X, Gao LL, Li B, Zhao TY, Zhang QW, Zou JX, Li MY, Guo YM, Guo Y, Pan XF. Efficacy differences of electroacupuncture with single acupoint or matching acupoints for chemotherapy-induced nausea and vomiting: study protocol for a randomized controlled trial. Trials. 2017 Oct 13;18(1):477. doi: 10.1186/s13063-017-2186-y.
PubMed 29029639
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Chemotherapy-Induced Nausea and Vomiting: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02195921
- Acronym / sponsor ID
- 2014CB543201-02
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Tianjin University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 21 Jul 2014 (estimated)
- Results
- Posted 11 Feb 2021
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 is more effective than a single point by electroacupuncture in the management of chemotherapy-induced nausea and vomiting .
Detailed description
Patients were assigned to Four sessions of electroacupuncture(EA) at the CV12, ST36, CV12+ST36 acupoints or antiemetic therapy over 5 days. primary and secondary outcomes and Adverse Eventswill be assessed.
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 CV12 | Experimental | Other: single point Zhongwan(CV12) plus antiemetic drugchoose 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 treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days. Received routine antiemetic treatment. |
| Single point ST36 | Experimental | Other: single point Zusanli(ST36) plus antiemetic drugchoose another single point Zusanli（ST36）.Zusanli(ST36):On the anterior aspect of the leg, on the line connecting ST35 with ST41, 3 B-cun inferior to ST35，located on the tibialis anterior muscle..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 treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days. Received routine antiemetic treatment. |
| ST36+CV12 acupoints | Experimental | Other: Zusanli(ST36)and Zhongwan(CV12) plus antiemetic drugChoose both Zusanli(ST36) and Zhongwan（CV12）.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 treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days. Received routine antiemetic treatment. |
| only antiemetics | Active comparator | Drug: only antiemetic drugThe control group will receive standard antiemetics alone. Standard antiemetics for all groups are 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 chemtherapy,and lasting for 3-5days. If nausea and/or vomiting is persistent and failed to respond to the antiemetic treatment , based on the experience of each clinician, the other advanced 5-HT3 antagonist or a neurokinin 1 antagonist(NK-1) will be chosen. |
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 he 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 Zhongwan(CV12) plus antiemetic drugAll participants were supine in the hospital bed. A disposable sterile acupuncture needle (ø 0.30 × 40 mm, Hwato) was inserted vertically at approximately 20-30 mm until "De Qi" (sensation of soreness, numbness, distension, etc. around the acupoint) was reported by the participants. Then, the needle handle was clamped via a metal clip to connect to the positive electrode of the electric acupuncture apparatus (Huatuo, SDZ-V model, Suzhou Medical Appliance). Another reference electrode was placed 1 cm above the CV12 acupoints of the stimulation point, where no acupoints or meridians passed through. A dilatational wave at a frequency of 2/10 Hz and a current intensity at the highest level tolerated by the patient, with a maximum intensity no more than 10 mA, were used to deliver the EA stimulation. People in the intervention groups were offered a standardized 30-minute EA session once daily from the 1st day of the four-day chemotherapy cycle. | Other | Single point CV12 |
| single point Zusanli(ST36) plus antiemetic drugA disposable sterile acupuncture needle (ø 0.30 × 40 mm, Hwato) was inserted vertically at approximately 20-30 mm until "De Qi" (sensation of soreness, numbness, distension, etc. around the acupoint) was reported by the participants. Then, the needle handle was clamped via a metal clip to connect to the positive electrode of the electric acupuncture apparatus (Huatuo, SDZ-V model, Suzhou Medical Appliance). Another reference electrode was placed 1cm below ST36 acupoints of the stimulation point, respectively, where no acupoints or meridians passed through. A dilatational wave at a frequency of 2/10 Hz and a current intensity at the highest level tolerated by the patient, with a maximum intensity no more than 10 mA, were used to deliver the EA stimulation. People in the intervention groups were offered a standardized 30-minute EA session once daily from the 1st day of the four-day chemotherapy cycle. | Other | Single point ST36 |
| Zusanli(ST36)and Zhongwan(CV12) plus antiemetic drugStimulating both Zusanli(ST36)and Zhongwan(CV12) | Other | ST36+CV12 acupoints |
| only antiemetic drugreceived routine antiemetic treatment | Drug | only antiemetics |
Primary outcome
Percentage of Participants With Nausea
Time frame: 5 days
Percentage of participants with nausea was assessed by visual analog scale (VAS) ranging from 0 (no nausea) to 10 (worst nausea). A score of 0 means no nausea for a portion of the patient's assessment.
Number of Times Vomiting Occurs After Chemotherapy
Time frame: 5 days
The number of times vomiting occurs after chemotherapy for each participant during 0-120 hours. The evaluator completed daily diaries for each time point.
Rhodes Index of Nausea, Vomiting and Retching
Time frame: 5 days
The RINVR scale has 8 items . The scale divides the occurrence of nausea , vomiting , and retching within 12 hours of tumor chemotherapy patients into 5 grades , which are scored from 0 to 4 points . The lower the score , the better . The RINVR scale can be divided into three dimensions : symptom experience time , symptom frequency and symptom severity .
Percentage of Participants With Nausea and Number of Times of Vomiting Occurs After Chemotherapy
Time frame: 5 days
Rhodes Index of Nausea, Vomiting and Retching was replaced by percentage of participants with nausea (assessed by VAS) and number of times of vomiting occurs which were recorded in the first and second primary outcome.
4 secondary outcomes
Grading of Constipation and Diarrhea
Time frame: 5 days
Electrogastrogram
Time frame: 5 days
the Assessment of Quality of Life
Time frame: 5 days
the Assessment of Anxiety and Depression
Time frame: 5 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29029639Chen B, Guo Y, Zhao X, Gao LL, Li B, Zhao TY, Zhang QW, Zou JX, Li MY, Guo YM, Guo Y, Pan XF. Efficacy differences of electroacupuncture with single acupoint or matching acupoints for chemotherapy-induced nausea and vomiting: study protocol for a randomized controlled trial. Trials. 2017 Oct 13;18(1):477. doi: 10.1186/s13063-017-2186-y.
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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.
Yi Guo study director
Tianjin University of Traditional Chinese Medicine
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 Zhongwan(CV12) plus antiemetic drug, single point Zusanli(ST36) plus antiemetic drug and Zusanli(ST36)and Zhongwan(CV12) plus antiemetic drug in people with 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 11 Feb 2021. 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?
Yes. Results are posted in the registry (first posted 11 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Nausea (time frame: 5 days). The study lists 4 primary outcomes in all. 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 NCT02195921, 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 11 Feb 2021.