Clinical trial NCT02195908: The Different Effectiveness of Single Acupoint（PC6 or CV12) vs Matching Acupoints(PC6 and CV12) in Chemotherapy-induced Nausea and Vomiting
Official title: The Comparative Study on the Effectiveness of Single Acupoint and Matching Acupoints.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: to Evaluate the Effectiveness of Acupucnture in the Management of Chemotherapy-induced Nausea and Vomiting
Lead sponsor: Tianjin University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: National Basic Research Program, China
First posted: 2014-07-21
Enrollment: 160
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 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

Primary outcomes:
measure: the frequency of Nausea and Vomiting
timeFrame: 6days
Secondary outcomes:
measure: the grading of constipation and diarrhea
timeFrame: 3 weeks
measure: electrogastrogram
timeFrame: 3 weeks
measure: the assessment of quality of life
timeFrame: 3 weeks
measure: the assessment of Anxiety and Depression
timeFrame: 3 weeks
Other outcomes:
measure: blood routine examination
timeFrame: 3 weeks
measure: electrocardiogram
timeFrame: 3 weeks
measure: hepatic and renal function
timeFrame: 3 weeks
measure: other adverse effect during the chemotherapy
timeFrame: 3 weeks
Locations:
city: Tianjin
country: China
facility: Tianjin University of TCM
state: Tianjin
Study officials:
References:
citation: Chen B, Hu SX, Liu BH, Zhao TY, Li B, Liu Y, Li MY, Pan XF, Guo YM, Chen ZL, Guo Y. Efficacy and safety of electroacupuncture with different acupoints for chemotherapy-induced nausea and vomiting: study protocol for a randomized controlled trial. Trials. 2015 May 12;16:212. doi: 10.1186/s13063-015-0734-x.