The Comparative Study on the Efficacy and Safety of Single Acupoint and Matching Acupoints

NCT ID: NCT03061396

Last Updated: 2018-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-17
• Study Completion Date: 2018-05-28

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

Electro-acupuncture; Chemotherapy-induced Nausea and Vomiting

Study Design

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

Study Groups

Electroacupuncture Single point

Single point PC6 means there is only one acupoint to be chosen: Neiguan(PC6)

Group Type: EXPERIMENTAL

Single points PC6

Intervention Type: OTHER

Choose Neiguan(PC6)of double upper limb.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 electrode.Frequency is 2/10 hertz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10 milliampere. And plus 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron, Tropisetron，Granisetron or Ondansetron) and dexamethasone.

Electroacupuncture Matching points

There are three acupoints to be chosen:Bilateral Neiguan(PC6)and Zhongwan(CV12)

Group Type: EXPERIMENTAL

Matching points PC6+CV12

Intervention Type: OTHER

Choose both Neiguan(PC6) and Zhongwan point(CV12).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 electrode.Frequency is 2/10 hertz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10 milliampere. And plus 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron, Tropisetron，Granisetron or Ondansetron) and dexamethasone.

Interventions

Matching points PC6+CV12

Choose both Neiguan(PC6) and Zhongwan point(CV12).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 electrode.Frequency is 2/10 hertz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10 milliampere. And plus 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron, Tropisetron，Granisetron or Ondansetron) and dexamethasone.

Intervention Type: OTHER

Single points PC6

Choose Neiguan(PC6)of double upper limb.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 electrode.Frequency is 2/10 hertz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10 milliampere. And plus 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron, Tropisetron，Granisetron or Ondansetron) and dexamethasone.

Intervention Type: OTHER

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 age 18 years to 80 years

4. Patients receiving chemotherapy both outpatients and inpatients

5. Patients receiving chemotherapy regime with high risk of causing vomiting: cisplatin ≥60 mg/m2, or joint chemotherapy regime of Anthracyclines (Adriamycin≥ 40 mg/ m2 or epirubicin≥60 mg/m2), Dacarbazine or Carboplatin（area under the curve greater than 5mg/ml/min）

6. Life expectancy > 6 months

Exclusion Criteria

1. To receive radiotherapy and chemotherapy

2. Gastrointestinal tumors

3. Patients with serious liver disease or abnormal hepatorenal function (Aspartate Aminotransferase, Alanine Aminotransferase , and Total Bilirubin are 3 times more than normal, blood urea nitrogen and Cr are 2 times more than normal)

4. Presence of cardiac pacemaker

5. Inflammatory skin reaction

6. Nausea and/or vomiting resulting from opioids or metabolic imbalance (electrolytic 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. Patients with brain metastases or symptoms of intracranial hypertension

10. Nausea and/or vomiting resulting from other diseases(i.e.,sympathetic cervical dispositions, Meniere's syndrome)

11. Women in pregnant and lactating period

12. Refusal to sign informed consent, rejection of randomization into intervention groups.

• 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

West China Hospital

OTHER

Sponsor Role: collaborator

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: collaborator

Gansu Provincial Cancer Hospital

UNKNOWN

Sponsor Role: collaborator

Henan Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Tianjin University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Yi Guo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tianjin University of TCM

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Guo Yi, Doc

Role: primary

tjutcmacupuncture@163.com

13920921016

Other Identifiers

2014CB543201-03

Identifier Type: -

Identifier Source: org_study_id