The Comparative Study on the Efficacy and Safety of Single Acupoint and Matching Acupoints

February 8, 2018 updated by: Yi Guo, Tianjin University of Traditional Chinese Medicine

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
208

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300193

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Be diagnosed as cancer and need to accept chemotherapy
  2. The score of Karnofsky ≥70
  3. Patients of either gender and age 18 years to 80 years
  4. Patients receiving chemotherapy both outpatients and inpatients
  5. 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）
  6. Life expectancy > 6 months

Exclusion Criteria:

  1. To receive radiotherapy and chemotherapy
  2. Gastrointestinal tumors
  3. 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)
  4. Presence of cardiac pacemaker
  5. Inflammatory skin reaction
  6. Nausea and/or vomiting resulting from opioids or metabolic imbalance (electrolytic disturbances)
  7. Patients unable to provide self-care or communication
  8. Nausea and/or vomiting resulting from mechanical risk factors (i.e.,intestinal obstruction)
  9. Patients with brain metastases or symptoms of intracranial hypertension
  10. Nausea and/or vomiting resulting from other diseases(i.e.,sympathetic cervical dispositions, Meniere's syndrome)
  11. Women in pregnant and lactating period
  12. Refusal to sign informed consent, rejection of randomization into intervention groups.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Electroacupuncture Single point
Single point PC6 means there is only one acupoint to be chosen: Neiguan(PC6)
Other: Single points PC6
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.
Experimental: Electroacupuncture Matching points
There are three acupoints to be chosen:Bilateral Neiguan(PC6)and Zhongwan(CV12)
Other: Matching points PC6+CV12
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6weeks
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.
6weeks
Nausea and Vomiting visual analogic scale (VAS)
Time Frame: 6weeks
6weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tcm Gastro-intestinal evaluation
Time Frame: 3weeks
3weeks
the grading of constipation ,diarrhea and decrease in appetite
Time Frame: 3weeks
Number of participants with constipation ,diarrhea and decrease events as assessed by CTCAE v4.0
3weeks
Electrogastrogram
Time Frame: 3weeks
3weeks
Hospital Anxiety and Depression Scale
Time Frame: 3weeks
3weeks
Functional Assessment of Cancer Treatment - General scale4.0
Time Frame: 3weeks
3weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Abnormal Laboratory Values
Time Frame: 6weeks
the number of blood cells,serumAlanine aminotransferase,Aspertate，Aminotransferase,total bilirubin,Creatinine，blood sodium，blood potassium
6weeks
cardial electrical activity
Time Frame: 6weeks
6weeks
other adverse effect during the chemotherapy
Time Frame: 6weeks
6weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tianjin University of Traditional Chinese Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
West China Hospital
Tianjin Medical University Cancer Institute and Hospital
Henan Provincial People's Hospital
National Basic Research Program, China
Gansu Provincial Cancer Hospital

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 17, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 28, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 28, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014CB543201-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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