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

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ClinicalTrials.gov Identifier: NCT03061396
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : February 9, 2018
Sponsor:
Collaborators:
National Basic Research Program, China
West China Hospital
Tianjin Medical University Cancer Institute and Hospital
Gansu Provincial Cancer Hospital
Henan Provincial Cancer Hospital
Information provided by (Responsible Party):
Yi Guo, Tianjin University of Traditional Chinese Medicine

Tracking Information
First Submitted Date  ICMJE February 5, 2017
First Posted Date  ICMJE February 23, 2017
Last Update Posted Date February 9, 2018
Actual Study Start Date  ICMJE February 17, 2017
Estimated Primary Completion Date April 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2017)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03061396 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2017)
  • Tcm Gastro-intestinal evaluation [ Time Frame: 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
  • Electrogastrogram [ Time Frame: 3weeks ]
  • Hospital Anxiety and Depression Scale [ Time Frame: 3weeks ]
  • Functional Assessment of Cancer Treatment - General scale4.0 [ Time Frame: 3weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 17, 2017)
  • 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
  • cardial electrical activity [ Time Frame: 6weeks ]
  • other adverse effect during the chemotherapy [ Time Frame: 6weeks ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Comparative Study on the Efficacy and Safety of Single Acupoint and Matching Acupoints
Official Title  ICMJE The Different Effectiveness of Single Acupoint vs Matching Acupoints in Chemotherapy-induced Nausea and Vomiting:A Multicenter, Randomized, Controlled Clinical Trial
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Electro-acupuncture
  • Chemotherapy-induced Nausea and Vomiting
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Electroacupuncture Single point
    Single point PC6 means there is only one acupoint to be chosen: Neiguan(PC6)
    Intervention: Other: Single points PC6
  • Experimental: Electroacupuncture Matching points
    There are three acupoints to be chosen:Bilateral Neiguan(PC6)and Zhongwan(CV12)
    Intervention: Other: Matching points PC6+CV12
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 17, 2017)
208
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 28, 2018
Estimated Primary Completion Date April 28, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03061396
Other Study ID Numbers  ICMJE 2014CB543201-03
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yi Guo, Tianjin University of Traditional Chinese Medicine
Study Sponsor  ICMJE Tianjin University of Traditional Chinese Medicine
Collaborators  ICMJE
  • National Basic Research Program, China
  • West China Hospital
  • Tianjin Medical University Cancer Institute and Hospital
  • Gansu Provincial Cancer Hospital
  • Henan Provincial Cancer Hospital
Investigators  ICMJE Not Provided
PRS Account Tianjin University of Traditional Chinese Medicine
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP