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NCT Number: NCT02195921

Acupuncture for Chemotherapy-Induced Nausea and Vomiting

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 .

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Key information

Conditions

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 Traditional Chinese Medicine

Tianjin, Tianjin Municipality, 301617, China

About this study

Patients were assigned to Four sessions of electroacupuncture(EA) at the CV12, ST36, CV12+ST36 acupoints or antiemetic therapy over 5 days. primary and secondary outcomes and Adverse Eventswill be assessed.

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 he 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 Zhongwan(CV12) plus antiemetic drug

Other

All participants were supine in the hospital bed. A disposable sterile acupuncture needle (ø 0.30 × 40 mm, Hwato) was inserted vertically at approximately 20-30 mm until "De Qi" (sensation of soreness, numbness, distension, etc. around the acupoint) was reported by the participants. Then, the needle handle was clamped via a metal clip to connect to the positive electrode of the electric acupuncture apparatus (Huatuo, SDZ-V model, Suzhou Medical Appliance). Another reference electrode was placed 1 cm above the CV12 acupoints of the stimulation point, where no acupoints or meridians passed through. A dilatational wave at a frequency of 2/10 Hz and a current intensity at the highest level tolerated by the patient, with a maximum intensity no more than 10 mA, were used to deliver the EA stimulation. People in the intervention groups were offered a standardized 30-minute EA session once daily from the 1st day of the four-day chemotherapy cycle.

single point Zusanli(ST36) plus antiemetic drug

Other

A disposable sterile acupuncture needle (ø 0.30 × 40 mm, Hwato) was inserted vertically at approximately 20-30 mm until "De Qi" (sensation of soreness, numbness, distension, etc. around the acupoint) was reported by the participants. Then, the needle handle was clamped via a metal clip to connect to the positive electrode of the electric acupuncture apparatus (Huatuo, SDZ-V model, Suzhou Medical Appliance). Another reference electrode was placed 1cm below ST36 acupoints of the stimulation point, respectively, where no acupoints or meridians passed through. A dilatational wave at a frequency of 2/10 Hz and a current intensity at the highest level tolerated by the patient, with a maximum intensity no more than 10 mA, were used to deliver the EA stimulation. People in the intervention groups were offered a standardized 30-minute EA session once daily from the 1st day of the four-day chemotherapy cycle.

Zusanli(ST36)and Zhongwan(CV12) plus antiemetic drug

Other

Stimulating both Zusanli(ST36)and Zhongwan(CV12)

only antiemetic drug

Drug

received routine antiemetic treatment

Primary outcomes

  1. Percentage of Participants With Nausea

    Time frame: 5 days

    Percentage of participants with nausea was assessed by visual analog scale (VAS) ranging from 0 (no nausea) to 10 (worst nausea). A score of 0 means no nausea for a portion of the patient's assessment.

  2. Number of Times Vomiting Occurs After Chemotherapy

    Time frame: 5 days

    The number of times vomiting occurs after chemotherapy for each participant during 0-120 hours. The evaluator completed daily diaries for each time point.

  3. Rhodes Index of Nausea, Vomiting and Retching

    Time frame: 5 days

    The RINVR scale has 8 items . The scale divides the occurrence of nausea , vomiting , and retching within 12 hours of tumor chemotherapy patients into 5 grades , which are scored from 0 to 4 points . The lower the score , the better . The RINVR scale can be divided into three dimensions : symptom experience time , symptom frequency and symptom severity .

  4. Percentage of Participants With Nausea and Number of Times of Vomiting Occurs After Chemotherapy

    Time frame: 5 days

    Rhodes Index of Nausea, Vomiting and Retching was replaced by percentage of participants with nausea (assessed by VAS) and number of times of vomiting occurs which were recorded in the first and second primary outcome.

Secondary outcomes

  1. Grading of Constipation and Diarrhea

    Time frame: 5 days

    The grading of constipation and diarrhea.We deleted this evaluation method due to weak correlation.

  2. Electrogastrogram

    Time frame: 5 days

    We deleted this evaluation method due to weak correlation.

  3. the Assessment of Quality of Life

    Time frame: 5 days

    Assessed by the Functional Assessment of Cancer Treatment-General (FACT-G) .The FACT-G includes 27 items and is divided among 4 subscales: physical well-being (PWB), functional well-being (FWB), social/family well-being (SWB), and emotional well-being (EWB). The total FACT-G score ranges from 0 to 108 and is calculated by the sum of the subscales, with higher scores indicating greater functional status

  4. the Assessment of Anxiety and Depression

    Time frame: 5 days

    Assessed by Hospital Anxiety and Depression Scale (HADS scale). It includes fourteen items, seven of which assess anxiety and the other seven assess depression (30). The total scores range from 0 to 21 for depression and anxiety, respectively, with higher scores indicating more depression and anxiety.

Other outcomes

  1. Blood Routine Examination

    Time frame: 5 days

    We deleted this evaluation method due to weak correlation.

  2. Electrocardiogram

    Time frame: 5 days

    We deleted this evaluation method due to weak correlation.

  3. Hepatic and Renal Function

    Time frame: 5 days

    We deleted this evaluation method due to weak correlation.

  4. Other Adverse Effect During the Chemotherapy

    Time frame: 5 days

Sponsors and collaborators

Lead sponsor

Tianjin University of Traditional Chinese Medicine

Other

Registry information

Official study title

Acupuncture for Chemotherapy-Induced Nausea and Vomiting: A Randomized Clinical Trial

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jul 21, 2014
Registry last updated
Feb 11, 2021

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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