Clinical trial NCT02195921: Acupuncture for Chemotherapy-Induced Nausea and Vomiting
Official title: Acupuncture for Chemotherapy-Induced Nausea and Vomiting: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chemotherapy-induced Nausea and Vomiting
Lead sponsor: Tianjin University of Traditional Chinese Medicine
Sponsor class: OTHER
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 is more effective than a single point by electroacupuncture in the management of chemotherapy-induced nausea and vomiting .

Detailed description: Patients were assigned to Four sessions of electroacupuncture(EA) at the CV12, ST36, CV12+ST36 acupoints or antiemetic therapy over 5 days. primary and secondary outcomes and Adverse Eventswill be assessed.

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 he 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: Percentage of Participants With Nausea
timeFrame: 5 days
measure: Number of Times Vomiting Occurs After Chemotherapy
timeFrame: 5 days
measure: Rhodes Index of Nausea, Vomiting and Retching
timeFrame: 5 days
measure: Percentage of Participants With Nausea and Number of Times of Vomiting Occurs After Chemotherapy
timeFrame: 5 days
Secondary outcomes:
measure: Grading of Constipation and Diarrhea
timeFrame: 5 days
measure: Electrogastrogram
timeFrame: 5 days
measure: the Assessment of Quality of Life
timeFrame: 5 days
measure: the Assessment of Anxiety and Depression
timeFrame: 5 days
Other outcomes:
measure: Blood Routine Examination
timeFrame: 5 days
measure: Electrocardiogram
timeFrame: 5 days
measure: Hepatic and Renal Function
timeFrame: 5 days
measure: Other Adverse Effect During the Chemotherapy
timeFrame: 5 days
Locations:
city: Tianjin
country: China
facility: Tianjin University of Traditional Chinese Medicine
state: Tianjin
Study officials:
affiliation: Tianjin University of Traditional Chinese Medicine
name: Yi Guo
role: STUDY_DIRECTOR
References:
citation: Chen B, Guo Y, Zhao X, Gao LL, Li B, Zhao TY, Zhang QW, Zou JX, Li MY, Guo YM, Guo Y, Pan XF. Efficacy differences of electroacupuncture with single acupoint or matching acupoints for chemotherapy-induced nausea and vomiting: study protocol for a randomized controlled trial. Trials. 2017 Oct 13;18(1):477. doi: 10.1186/s13063-017-2186-y.