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

Not Applicable

Completed

• Conditions: to Evaluate the Effectiveness of Acupucnture in the Management of Chemotherapy-induced Nausea and Vomiting
• Interventions: Other: 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; Drug: only antiemetic drug

• Registration Number: NCT02195908
• Lead Sponsor: Tianjin University of Traditional Chinese Medicine

Brief Summary

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 .

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-17
• Study First Submitted QC: 2014-07-17
• Study First Posted: 2014-07-21
• Study Start: 2014-08
• Primary Completion: 2015-07
• Study Completion: 2015-10
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-05
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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 the 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single point PC6	single point Neiguan(PC6) plus antiemetic drug	choose single point: Neiguan(PC6).Neiguan(PC6): On the anterior aspect of the forearm,between the tendons of the palmaris longus and the flexor carpi radialis, 2 B-cun proximal to the palmar wrist crease.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 treatment is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.
Single point CV12	single point Zhongwan(CV12) plus antiemetic drug	choose another 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 treatment is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.
Matching points PC6+CV12	matching points Neiguan(PC6) and Zhongwan(CV12) plus antiemetic drug	Choose both Neiguan point(PC6) and Zhongwan point(CV12). Manipulating until achieving a "de Qi" sensation, then the needles are connected through a electro-acupuncture apparatus, the positive poles are linked to the needle, and the reference poles are 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 treatment is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.
only antiemetic	only antiemetic drug	The control group will receive standard antiemetic alone. Standard antiemetic for all groups is 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 chemotherapy, and lasting for 3-5 days.

Primary Outcome Measures

Name	Time	Method
the frequency of Nausea and Vomiting	6days

Secondary Outcome Measures

Name	Time	Method
the grading of constipation and diarrhea	3 weeks
electrogastrogram	3 weeks
the assessment of quality of life	3 weeks
the assessment of Anxiety and Depression	3 weeks

Trial Locations

Locations (1)

Tianjin University of TCM; 🇨🇳 Tianjin, Tianjin, China