Acupuncture for Chemotherapy-Induced Nausea and Vomiting

Not Applicable

Completed

Conditions: Chemotherapy-induced Nausea and Vomiting

Interventions: Other: single point Zhongwan(CV12) plus antiemetic drug
Other: Zusanli(ST36)and Zhongwan(CV12) plus antiemetic drug
Other: single point Zusanli(ST36) plus antiemetic drug
Drug: only antiemetic drug

Registration Number: NCT02195921

Lead Sponsor: 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 .

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 160

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single point CV12	single point Zhongwan(CV12) plus antiemetic drug	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.
ST36+CV12 acupoints	Zusanli(ST36)and Zhongwan(CV12) plus antiemetic drug	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.
Single point ST36	single point Zusanli(ST36) plus antiemetic drug	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.
only antiemetics	only antiemetic drug	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Nausea	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.
Number of Times Vomiting Occurs After Chemotherapy	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.
Rhodes Index of Nausea, Vomiting and Retching	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 .
Percentage of Participants With Nausea and Number of Times of Vomiting Occurs After Chemotherapy	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 Outcome Measures

Name	Time	Method
Grading of Constipation and Diarrhea	5 days	The grading of constipation and diarrhea.We deleted this evaluation method due to weak correlation.
Electrogastrogram	5 days	We deleted this evaluation method due to weak correlation.
the Assessment of Quality of Life	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
the Assessment of Anxiety and Depression	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.