to Evaluate the Effectiveness of Acupucnture in the Management of Chemotherapy-induced Nausea and Vomiting
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
OTHERsingle point Neiguan(PC6) plus antiemetic drug
OTHERmatching points Neiguan(PC6) and Zhongwan(CV12) plus antiemetic drug
Sponsors
National Basic Research Program, China
Tianjin University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the frequency of Nausea and Vomiting | 6days |
Secondary
| Measure | Time frame |
|---|---|
| electrogastrogram | 3 weeks |
| the assessment of quality of life | 3 weeks |
| the assessment of Anxiety and Depression | 3 weeks |
| the grading of constipation and diarrhea | 3 weeks |
Other
| Measure | Time frame |
|---|---|
| electrocardiogram | 3 weeks |
| hepatic and renal function | 3 weeks |
| other adverse effect during the chemotherapy | 3 weeks |
| blood routine examination | 3 weeks |
Countries
China
Outcome results
None listed