Chemotherapy-induced Nausea and Vomiting, Electro-acupuncture
Conditions
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.
Interventions
OTHERMatching 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.
OTHERSingle 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.
Sponsors
National Basic Research Program, China
West China Hospital
Tianjin Medical University Cancer Institute and Hospital
Gansu Provincial Cancer Hospital
Henan Provincial People's Hospital
Tianjin University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Control rates of Nausea and Vomiting | 6weeks | There is no emetic episodes, no rescue therapy, and no significant nausea from first day of antiemetic therapy to 5th day. |
| Nausea and Vomiting visual analogic scale (VAS) | 6weeks | — |
| Complete Response rates of Vomiting | 6weeks | There is no emetic episodes and no rescue therapy on first day of antiemetic therapy and second day to 5th day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tcm Gastro-intestinal evaluation | 3weeks | — |
| the grading of constipation ,diarrhea and decrease in appetite | 3weeks | Number of participants with constipation ,diarrhea and decrease events as assessed by CTCAE v4.0 |
| Functional Assessment of Cancer Treatment - General scale4.0 | 3weeks | — |
| Electrogastrogram | 3weeks | — |
| Hospital Anxiety and Depression Scale | 3weeks | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Abnormal Laboratory Values | 6weeks | the number of blood cells,serumAlanine aminotransferase,Aspertate，Aminotransferase,total bilirubin,Creatinine，blood sodium，blood potassium |
| other adverse effect during the chemotherapy | 6weeks | — |
| cardial electrical activity | 6weeks | — |
Countries
China
Outcome results
None listed