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

NCT02195908 | Completed DMC

• 1 other identifier: 2014CB543201-01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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 .

Conditions

to Evaluate the Effectiveness of Acupucnture in the Management of Chemotherapy-induced Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• the frequency of Nausea and Vomiting

  6days

Secondary Outcomes (4)

• 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

Other Outcomes (4)

• blood routine examination

  3 weeks

• electrocardiogram

  3 weeks

• hepatic and renal function

  3 weeks

Study Arms (4)

Single point PC6

EXPERIMENTAL

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.

Other: single point Neiguan(PC6) plus antiemetic drug

Single point CV12

EXPERIMENTAL

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.

Other: single point Zhongwan(CV12) plus antiemetic drug

Matching points PC6+CV12

EXPERIMENTAL

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.

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

only antiemetic

ACTIVE COMPARATOR

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.

Drug: only antiemetic drug

Interventions

single point Neiguan(PC6) plus antiemetic drug OTHER

Single point PC6

single point Zhongwan(CV12) plus antiemetic drug OTHER

Single point CV12

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

Matching points PC6+CV12

only antiemetic drug DRUG

only antiemetic

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 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.

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
• National Basic Research Program, China: collaborator

Study Sites (1)

Tianjin University of TCM

Tianjin, Tianjin Municipality, 300193, China

Location

Related Publications (1)

• Chen B, Hu SX, Liu BH, Zhao TY, Li B, Liu Y, Li MY, Pan XF, Guo YM, Chen ZL, Guo Y. Efficacy and safety of electroacupuncture with different acupoints for chemotherapy-induced nausea and vomiting: study protocol for a randomized controlled trial. Trials. 2015 May 12;16:212. doi: 10.1186/s13063-015-0734-x.

  PMID: 25963295 DERIVED

MeSH Terms

Conditions

Vomiting

Condition Hierarchy (Ancestors)

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

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: the Dean of Acupuncture and Moxibustion College

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: July 21, 2014
• Study Start: August 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 8, 2020

Record last verified: 2020-10

Locations

CN (1)