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

NCT ID: NCT02195908

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2015-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Single point PC6

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.

Group Type: EXPERIMENTAL

single point Neiguan(PC6) plus antiemetic drug

Intervention Type: OTHER

Single point CV12

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.

Group Type: EXPERIMENTAL

single point Zhongwan(CV12) plus antiemetic drug

Intervention Type: OTHER

Matching points PC6+CV12

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.

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

only antiemetic

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.

Group Type: ACTIVE_COMPARATOR

only antiemetic drug

Intervention Type: DRUG

Interventions

single point Neiguan(PC6) plus antiemetic drug

Intervention Type: OTHER

single point Zhongwan(CV12) plus antiemetic drug

Intervention Type: OTHER

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

Intervention Type: OTHER

only antiemetic drug

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Basic Research Program, China

OTHER

Sponsor Role: collaborator

Tianjin University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Yi Guo

the Dean of Acupuncture and Moxibustion College

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tianjin University of TCM

Tianjin, Tianjin Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 25963295 (View on PubMed)

Other Identifiers

2014CB543201-01

Identifier Type: -

Identifier Source: org_study_id