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

Chemotherapy-induced Nausea and Vomiting Clinical Trial

Official title:

The Different Effectiveness of Single Acupoint vs Matching Acupoints in Chemotherapy-induced Nausea and Vomiting：A Multicenter, Randomized, Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03061396
• Other study ID #: 2014CB543201-03
• Status: Recruiting
• Phase: N/A
• First received: February 5, 2017
• Last updated: February 8, 2018
• Start date: February 17, 2017
• Est. completion date: May 28, 2018

Study information

• Verified date: February 2018
• Source: Tianjin University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 208
• Est. completion date: May 28, 2018
• Est. primary completion date: April 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• 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 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.

Related Conditions & MeSH terms

• Chemotherapy-induced Nausea and Vomiting
• Electro-acupuncture
• Nausea
• Vomiting

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
China	Tianjin University of TCM	Tianjin	Tianjin

Sponsors (6)

Lead Sponsor	Collaborator
Tianjin University of Traditional Chinese Medicine	Gansu Provincial Cancer Hospital, Henan Provincial Cancer Hospital, National Basic Research Program, China, Tianjin Medical University Cancer Institute and Hospital, West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Abnormal Laboratory Values	the number of blood cells,serumAlanine aminotransferase,Aspertate,Aminotransferase,total bilirubin,Creatinine,blood sodium,blood potassium	6weeks
Other	cardial electrical activity		6weeks
Other	other adverse effect during the chemotherapy		6weeks
Primary	Complete Control rates of Nausea and Vomiting	There is no emetic episodes, no rescue therapy, and no significant nausea from first day of antiemetic therapy to 5th day.	6weeks
Primary	Complete Response rates of Vomiting	There is no emetic episodes and no rescue therapy on first day of antiemetic therapy and second day to 5th day.	6weeks
Primary	Nausea and Vomiting visual analogic scale (VAS)		6weeks
Secondary	Tcm Gastro-intestinal evaluation		3weeks
Secondary	the grading of constipation ,diarrhea and decrease in appetite	Number of participants with constipation ,diarrhea and decrease events as assessed by CTCAE v4.0	3weeks
Secondary	Electrogastrogram		3weeks
Secondary	Hospital Anxiety and Depression Scale		3weeks
Secondary	Functional Assessment of Cancer Treatment - General scale4.0		3weeks