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

Chemotherapy-induced Nausea and Vomiting Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02478047
• Other study ID #: 2014CB543202-01
• Status: Not yet recruiting
• Phase: N/A
• First received: May 19, 2015
• Last updated: June 22, 2015
• Start date: June 2015
• Est. completion date: September 2016

Study information

• Verified date: May 2015
• Source: Tianjin University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chemotherapy-induced Nausea and Vomiting
• Nausea
• Vomiting

Intervention

Drug:
• 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.

Other:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
China	Tianjin University of TCM	Tianjin	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Tianjin University of Traditional Chinese Medicine	National Basic Research Program of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	the number of blood cells	the number of WBC,RBC,hemoglobin,PLT,the percents of GRA,LYM	3 weeks	Yes
Other	cardial electrical activity		3 weeks	Yes
Other	hepatic function	The Outcome Measures will be assessed by blood, the metrics of ALT,AST,TBIL is IU/L,IU/L,and µmol/L.	3 weeks	Yes
Other	other adverse effect during the chemotherapy		3 weeks	Yes
Other	renal function	The Outcome Measures will be assessed by blood, the metrics of BUN,Scr is mmol/L and µmol/L.	3 weeks	Yes
Primary	the frequency of Nausea and Vomiting		3 weeks	No
Primary	the extent of Nausea and Vomiting		3 weeks	No
Primary	Rhodes Index of Nausea, Vomiting and Retching		3 weeks	No
Secondary	the condition of constipation and diarrhea		3 weeks	Yes
Secondary	gastric electrical activity (electrogastrogram)		3 weeks	No
Secondary	the life quality of the patients		3 weeks	No
Secondary	the Anxiety and Depression of the patients		3 weeks	No