Chemotherapy-induced Nausea and VomitingNCT02478047
Comparative Effect Study Between Distal-proximal Point Association and Local Distribution Point Association in Chemotherapy-induced Nausea and Vomiting
A study testing only antiemetic (Ramosetron, Tropisetron and dexamethasone), Matching points ST36+CV12 plus antiemetic drug and Matching points PC6+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 distal-proximal point association is more effective than partial match point association 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
- Chemotherapy-induced Nausea and Vomiting
- What is being tested?
- only antiemetic (Ramosetron, Tropisetron and dexamethasone), Matching points ST36+CV12 plus antiemetic drug and Matching points PC6+CV12 plus antiemetic drug
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Sep 2016
- 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)
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 TCM
Tianjin, Tianjin Municipality, 300193
Guo Yi, Doc, 13920921016, tjutcmacupuncture@163.com
About this study
The purpose of this study is to clarify whether distal-proximal point association is more effective than partial match point association by electro-acupuncture in the management of chemotherapy-induced nausea and vomiting .
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Being tested
- only antiemetic (Ramosetron, Tropisetron and dexamethasone), Matching points ST36+CV12 plus antiemetic drug, Matching points PC6+CV12 plus antiemetic drug, Matching points CV13+CV12 plus antiemetic drug
- Keywords
- to Evaluate the Effectiveness of Acupucnture in the Management of Chemotherapy-induced Nausea and Vomiting
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
only antiemetic (Ramosetron, Tropisetron and dexamethasone)Drug
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.And plus antiemetic drug as the comparator group.
Matching points ST36+CV12 plus antiemetic drugOther
Choose both Zusanli(ST36) 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.And plus antiemetic drug as the comparator group.
Matching points PC6+CV12 plus antiemetic drugOther
Choose both Neiguan(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.And plus antiemetic drug as the comparator group.
Matching points CV13+CV12 plus antiemetic drugOther
Choose both Shangwan(CV13) 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.And plus antiemetic drug as the comparator group.
| Study group | Role | What they receive |
|---|---|---|
| only antiemetic | Active comparator | The participants in the control group received standard antiemetic alone. Standard antiemetic for all groups is based on American Society of Clinical Oncology cClinical pPractice gGuideline. The 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron, Tropisetron) and dexamethasone are administered before the chemotherapy treatment. Receives: Drug: only antiemetic (Ramosetron, Tropisetron and dexamethasone) |
| Matching points ST36+CV12 | Experimental | Not described Receives: Other: Matching points ST36+CV12 plus antiemetic drug |
| Matching points PC6+CV12 | Experimental | Not described Receives: Other: Matching points PC6+CV12 plus antiemetic drug |
| Matching points CV3+CV12 | Experimental | Not described Receives: Other: Matching points CV13+CV12 plus 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: 3 weeks
the extent of Nausea and Vomiting
Measured: 3 weeks
Rhodes Index of Nausea, Vomiting and Retching
Measured: 3 weeks
Secondary outcomes (4)
the condition of constipation and diarrhea
Measured: 3 weeks
gastric electrical activity (electrogastrogram)
Measured: 3 weeks
the life quality of the patients
Measured: 3 weeks
the Anxiety and Depression of the patients
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 posted23 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2016 (estimated)
- Study completionSep 2016 (estimated)
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 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
- 240 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
- Responsible party
- Principal investigator, Yi Guo, Tianjin University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478047
- Sponsor's protocol ID
- 2014CB543202-01
- Status last verified
- May 2015
- First submitted
- 19 May 2015
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gao L, Chen B, Zhang Q, Zhao T, Li B, Sha T, Zou J, Guo Y, Pan X, Guo Y. Acupuncture with different acupoint combinations for chemotherapy-induced nausea and vomiting: study protocol for a randomized controlled trial. BMC Complement Altern Med. 2016 Nov 8;16(1):441. doi: 10.1186/s12906-016-1425-1.
PubMed 27821107
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect Study Between Distal-proximal Point Association and Local Distribution Point Association in Chemotherapy-induced Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT02478047
- Acronym / sponsor ID
- 2014CB543202-01
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Keywords
- to Evaluate the Effectiveness of Acupucnture in the Management of Chemotherapy-induced Nausea and Vomiting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Tianjin University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- National Basic Research Program, China
- Study start
- Jun 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 23 Jun 2015 (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 distal-proximal point association is more effective than partial match point association 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 |
|---|---|---|
| only antiemetic | Active comparator | Drug: only antiemetic (Ramosetron, Tropisetron and dexamethasone)The participants in the control group received standard antiemetic alone. Standard antiemetic for all groups is based on American Society of Clinical Oncology cClinical pPractice gGuideline. The 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron, Tropisetron) and dexamethasone are administered before the chemotherapy treatment. |
| Matching points ST36+CV12 | Experimental | Other: Matching points ST36+CV12 plus antiemetic drug |
| Matching points PC6+CV12 | Experimental | Other: Matching points PC6+CV12 plus antiemetic drug |
| Matching points CV3+CV12 | Experimental | Other: Matching points CV13+CV12 plus antiemetic drug |
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 |
|---|---|---|
| only antiemetic (Ramosetron, Tropisetron and dexamethasone)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.And plus antiemetic drug as the comparator group. | Drug | only antiemetic |
| Matching points ST36+CV12 plus antiemetic drugChoose both Zusanli(ST36) 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.And plus antiemetic drug as the comparator group. | Other | Matching points ST36+CV12 |
| Matching points PC6+CV12 plus antiemetic drugChoose both Neiguan(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.And plus antiemetic drug as the comparator group. | Other | Matching points PC6+CV12 |
| Matching points CV13+CV12 plus antiemetic drugChoose both Shangwan(CV13) 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.And plus antiemetic drug as the comparator group. | Other | Matching points CV3+CV12 |
Primary outcome
the frequency of Nausea and Vomiting
Time frame: 3 weeks
the extent of Nausea and Vomiting
Time frame: 3 weeks
Rhodes Index of Nausea, Vomiting and Retching
Time frame: 3 weeks
4 secondary outcomes
the condition of constipation and diarrhea
Time frame: 3 weeks
gastric electrical activity (electrogastrogram)
Time frame: 3 weeks
the life quality of the patients
Time frame: 3 weeks
the Anxiety and Depression of the patients
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
- Derived from this study: PubMed 27821107Gao L, Chen B, Zhang Q, Zhao T, Li B, Sha T, Zou J, Guo Y, Pan X, Guo Y. Acupuncture with different acupoint combinations for chemotherapy-induced nausea and vomiting: study protocol for a randomized controlled trial. BMC Complement Altern Med. 2016 Nov 8;16(1):441. doi: 10.1186/s12906-016-1425-1.
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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 only antiemetic (Ramosetron, Tropisetron and dexamethasone), Matching points ST36+CV12 plus antiemetic drug and Matching points PC6+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: status not confirmed, as of the sponsor's last update on 23 Jun 2015. 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?
the frequency of Nausea and Vomiting (time frame: 3 weeks). 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?
On the ClinicalTrials.gov record for NCT02478047, 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 23 Jun 2015.