Chemotherapy-induced Nausea and Vomiting
Conditions
Keywords
to Evaluate the Effectiveness of Acupucnture in the Management of Chemotherapy-induced Nausea and Vomiting
Brief 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 .
Interventions
DRUGonly 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.
OTHERMatching 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.
OTHERMatching 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.
OTHERMatching 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.
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 | 3 weeks |
| Rhodes Index of Nausea, Vomiting and Retching | 3 weeks |
| the extent of Nausea and Vomiting | 3 weeks |
Secondary
| Measure | Time frame |
|---|---|
| gastric electrical activity (electrogastrogram) | 3 weeks |
| the condition of constipation and diarrhea | 3 weeks |
| the life quality of the patients | 3 weeks |
| the Anxiety and Depression of the patients | 3 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| hepatic function | 3 weeks | The Outcome Measures will be assessed by blood, the metrics of ALT,AST,TBIL is IU/L,IU/L,and μmol/L. |
| cardial electrical activity | 3 weeks | — |
| renal function | 3 weeks | The Outcome Measures will be assessed by blood, the metrics of BUN,Scr is mmol/L and μmol/L. |
| other adverse effect during the chemotherapy | 3 weeks | — |
| the number of blood cells | 3 weeks | the number of WBC,RBC,hemoglobin,PLT,the percents of GRA,LYM |
Countries
China
Outcome results
None listed