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Completed

NCT Number: NCT02195908

The Different Effectiveness of Single Acupoint（PC6 or CV12) vs Matching Acupoints(PC6 and CV12) in Chemotherapy-induced Nausea and Vomiting

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 .

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Key information

Conditions

to Evaluate the Effectiveness of Acupucnture in the Management of Chemotherapy-induced Nausea and Vomiting Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tianjin University of TCM

Tianjin, Tianjin Municipality, 300193, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)
  • 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

Treatment and study plan

single point Neiguan(PC6) plus antiemetic drug

Other

single point Zhongwan(CV12) plus antiemetic drug

Other

matching points Neiguan(PC6) and Zhongwan(CV12) plus antiemetic drug

Other

only antiemetic drug

Drug

Primary outcomes

  1. the frequency of Nausea and Vomiting

    Time frame: 6days

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Tianjin University of Traditional Chinese Medicine

Other

Collaborators

  • National Basic Research Program, China

Registry information

Official study title

The Comparative Study on the Effectiveness of Single Acupoint and Matching Acupoints.

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 21, 2014
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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