Clinical trial NCT03061396: The Comparative Study on the Efficacy and Safety of Single Acupoint and Matching Acupoints
Official title: The Different Effectiveness of Single Acupoint vs Matching Acupoints in Chemotherapy-induced Nausea and Vomiting：A Multicenter, Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Electro-acupuncture
Chemotherapy-induced Nausea and Vomiting
Lead sponsor: Tianjin University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: National Basic Research Program, China
name: West China Hospital
name: Tianjin Medical University Cancer Institute and Hospital
name: Gansu Provincial Cancer Hospital
name: Henan Provincial People's Hospital
First posted: 2017-02-23
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Complete Control rates of Nausea and Vomiting
timeFrame: 6weeks
measure: Complete Response rates of Vomiting
timeFrame: 6weeks
measure: Nausea and Vomiting visual analogic scale (VAS)
timeFrame: 6weeks
Secondary outcomes:
measure: Tcm Gastro-intestinal evaluation
timeFrame: 3weeks
measure: the grading of constipation ,diarrhea and decrease in appetite
timeFrame: 3weeks
measure: Electrogastrogram
timeFrame: 3weeks
measure: Hospital Anxiety and Depression Scale
timeFrame: 3weeks
measure: Functional Assessment of Cancer Treatment - General scale4.0
timeFrame: 3weeks
Other outcomes:
measure: Number of Participants With Abnormal Laboratory Values
timeFrame: 6weeks
measure: cardial electrical activity
timeFrame: 6weeks
measure: other adverse effect during the chemotherapy
timeFrame: 6weeks
Locations:
city: Tianjin
country: China
facility: Tianjin University of TCM
state: Tianjin
Study officials:
References: