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Trial record 1 of 1 for:    NCT02195921
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The Different Effectiveness of Single Acupoint(ST36 or CV12) vs Matching Acupoints(ST36 and CV12) in Chemotherapy-induced Nausea and Vomiting

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ClinicalTrials.gov Identifier: NCT02195921
Recruitment Status : Unknown
Verified July 2014 by Yi Guo, Tianjin University of Traditional Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : July 21, 2014
Last Update Posted : June 16, 2015
Sponsor:
Information provided by (Responsible Party):
Yi Guo, Tianjin University of Traditional Chinese Medicine

Brief 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 .

Condition or disease Intervention/treatment Phase
to Evaluate the Effectiveness of Acupucnture in the Management of Chemotherapy-induced Nausea and Vomiting Other: single point Neiguan(CV12) plus antiemetic drug Other: single point Zusanli(ST36) plus antiemetic drug Other: matching points Zusanli(ST36)and Neiguan(CV12) plus antiemetic drug Drug: only antiemetic drug Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : April 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single point CV12
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.
Other: single point Neiguan(CV12) plus antiemetic drug
Experimental: Single point ST36
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.
Other: single point Zusanli(ST36) plus antiemetic drug
Experimental: Matching points ST36+CV12
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.
Other: matching points Zusanli(ST36)and Neiguan(CV12) plus antiemetic drug
Active Comparator: only antiemetics
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.
Drug: only antiemetic drug



Primary Outcome Measures :
  1. the frequency of Nausea and Vomiting [ Time Frame: 3 weeks ]
  2. the grading of Nausea and Vomiting [ Time Frame: 3 weeks ]
  3. Rhodes Index of Nausea, Vomiting and Retching [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. the grading of constipation and diarrhea [ Time Frame: 3 weeks ]
  2. electrogastrogram [ Time Frame: 3 weeks ]
  3. the assessment of quality of life [ Time Frame: 3 weeks ]
  4. the assessment of Anxiety and Depression [ Time Frame: 3 weeks ]

Other Outcome Measures:
  1. blood routine examination [ Time Frame: 3 weeks ]
  2. electrocardiogram [ Time Frame: 3 weeks ]
  3. hepatic and renal function [ Time Frame: 3 weeks ]
  4. other adverse effect during the chemotherapy [ Time Frame: 3 weeks ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be diagnosed as cancer and need to accept chemotherapy.
  2. The score of Karnofsky ≥70
  3. Patients of either gender and older than 18 years
  4. Patients receiving chemotherapy both outpatients and inpatients
  5. Patients receiving chemotherapy either he first or multiple cycle, but the patient will be taken in only one time
  6. To receive chemotherapy containing cisplatin(DDP≥75mg/m2) or joint chemotherapy programmes of Anthracyclines(Adriamycin≥40mg/m2 or epirubicin≥60mg/m2)
  7. Life expectancy≥ 6 months
  8. Willing to participate in the study and be randomized into one of the four study groups.

Exclusion Criteria:

  1. To receive radiotherapy and chemotherapy
  2. Gastrointestinal tumors
  3. 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)
  4. Presence of cardiac pacemaker
  5. Active skin infection
  6. Nausea and/or vomiting resulting from opioids or metabolic imbalance (electrolyte 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. Brain metastases
  10. Women in pregnant and lactating period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02195921


Locations
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China, Tianjin
Tianjin University of TCM Recruiting
Tianjin, Tianjin, China, 300193
Contact: Guo Yi, Doc    13920921016    tjutcmacupuncture@163.com   
Sponsors and Collaborators
Tianjin University of Traditional Chinese Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yi Guo, the Dean of Acupuncture and Moxibustion College, Tianjin University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02195921    
Other Study ID Numbers: 2014CB543201-02
First Posted: July 21, 2014    Key Record Dates
Last Update Posted: June 16, 2015
Last Verified: July 2014
Additional relevant MeSH terms:
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Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents