Acupuncture for Chemotherapy-Induced Nausea and Vomiting

NCT02195921 | Completed Results DMC

• 1 other identifier: 2014CB543201-02
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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 .

Conditions

Chemotherapy-induced Nausea and Vomiting

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants With Nausea

  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.

  5 days

• Number of Times Vomiting Occurs After Chemotherapy

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

  5 days

• Rhodes Index of Nausea, Vomiting and Retching

  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 .

  5 days

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

  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.

  5 days

Secondary Outcomes (4)

• Grading of Constipation and Diarrhea

  5 days

• Electrogastrogram

  5 days

• the Assessment of Quality of Life

  5 days

• the Assessment of Anxiety and Depression

  5 days

Other Outcomes (4)

• Blood Routine Examination

  5 days

• Electrocardiogram

  5 days

• Hepatic and Renal Function

  5 days

Study Arms (4)

Single point CV12

EXPERIMENTAL

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. Received routine antiemetic treatment.

Other: single point Zhongwan(CV12) plus antiemetic drug

Single point ST36

EXPERIMENTAL

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. Received routine antiemetic treatment.

Other: single point Zusanli(ST36) plus antiemetic drug

ST36+CV12 acupoints

EXPERIMENTAL

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. Received routine antiemetic treatment.

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

only antiemetics

ACTIVE COMPARATOR

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

Interventions

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 CV12

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.

Single point ST36

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

Stimulating both Zusanli(ST36)and Zhongwan(CV12)

ST36+CV12 acupoints

only antiemetic drug DRUG

received routine antiemetic treatment

only antiemetics

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin University of Traditional Chinese Medicine: lead

Study Sites (1)

Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, 301617, China

Location

Related Publications (1)

• Chen B, Guo Y, Zhao X, Gao LL, Li B, Zhao TY, Zhang QW, Zou JX, Li MY, Guo YM, Guo Y, Pan XF. Efficacy differences of electroacupuncture with single acupoint or matching acupoints for chemotherapy-induced nausea and vomiting: study protocol for a randomized controlled trial. Trials. 2017 Oct 13;18(1):477. doi: 10.1186/s13063-017-2186-y.

  PMID: 29029639 DERIVED

MeSH Terms

Conditions

Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Acupuncture for Chemotherapy-Induced Nausea and Vomiting: A Randomized Clinical Trial
• Organization: Tianjin University of Traditional Chinese Medicine

guoyi_168@163.com

+86 13920921016

Study Officials

• Yi Guo

  Tianjin University of Traditional Chinese Medicine

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of Traditional Chinese Medicine School

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: July 21, 2014
• Study Start: April 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: January 1, 2017
• Last Updated: February 11, 2021
• Results First Posted: February 11, 2021

Record last verified: 2021-01

Locations

CN (1)