Comparative Effect Study Between Distal-proximal Point Association and Local Distribution Point Association in Chemotherapy-induced Nausea and Vomiting

NCT ID: NCT02478047

Last Updated: 2015-06-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-09-30

Brief Summary

The purpose of this study is to clarify whether distal-proximal point association is more effective than partial match point association by electro-acupuncture in the management of chemotherapy-induced nausea and vomiting .

Conditions

Chemotherapy-induced Nausea and Vomiting

Study Design

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

Study Groups

only antiemetic

The participants in the control group received standard antiemetic alone. Standard antiemetic for all groups is based on American Society of Clinical Oncology cClinical pPractice gGuideline. The 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron, Tropisetron) and dexamethasone are administered before the chemotherapy treatment.

Group Type: ACTIVE_COMPARATOR

only antiemetic (Ramosetron, Tropisetron and dexamethasone)

Intervention Type: 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.And plus antiemetic drug as the comparator group.

Matching points ST36+CV12

Group Type: EXPERIMENTAL

Matching points ST36+CV12 plus antiemetic drug

Intervention Type: OTHER

Choose both Zusanli(ST36) 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.And plus antiemetic drug as the comparator group.

Matching points PC6+CV12

Group Type: EXPERIMENTAL

Matching points PC6+CV12 plus antiemetic drug

Intervention Type: OTHER

Choose both Neiguan(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.And plus antiemetic drug as the comparator group.

Matching points CV3+CV12

Group Type: EXPERIMENTAL

Matching points CV13+CV12 plus antiemetic drug

Intervention Type: OTHER

Choose both Shangwan(CV13) 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.And plus antiemetic drug as the comparator group.

Interventions

only antiemetic (Ramosetron, Tropisetron and dexamethasone)

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.And plus antiemetic drug as the comparator group.

Intervention Type: DRUG

Matching points ST36+CV12 plus antiemetic drug

Choose both Zusanli(ST36) 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.And plus antiemetic drug as the comparator group.

Intervention Type: OTHER

Matching points PC6+CV12 plus antiemetic drug

Choose both Neiguan(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.And plus antiemetic drug as the comparator group.

Intervention Type: OTHER

Matching points CV13+CV12 plus antiemetic drug

Choose both Shangwan(CV13) 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.And plus antiemetic drug as the comparator group.

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 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

Facility Contacts

Guo Yi, Doc

Role: primary

tjutcmacupuncture@163.com

13920921016

References

Gao L, Chen B, Zhang Q, Zhao T, Li B, Sha T, Zou J, Guo Y, Pan X, Guo Y. Acupuncture with different acupoint combinations for chemotherapy-induced nausea and vomiting: study protocol for a randomized controlled trial. BMC Complement Altern Med. 2016 Nov 8;16(1):441. doi: 10.1186/s12906-016-1425-1.

Reference Type: DERIVED

PMID: 27821107 (View on PubMed)

Other Identifiers

2014CB543202-01

Identifier Type: -

Identifier Source: org_study_id