Clinical trial NCT02195921
Conditions: Chemotherapy-induced Nausea and Vomiting
Sponsor: Tianjin University of Traditional Chinese Medicine
Start date: 2015-04-01; Completion date: 2017-01-01
Enrollment: 160 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: choose single point:Zhongwan(CV12).Zhongwan(CV12):On the upper abdomen, 4 B-cun superior to the centre of the umbilicus, on the anterior median line.Manipulating until achieving a "de Qi" sensation,then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is 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 treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days. Received routine antiemetic treatment. arm 2: choose another single point Zusanli（ST36）.Zusanli(ST36):On the anterior aspect of the leg, on the line connecting ST35 with ST41, 3 B-cun inferior to ST35，located on the tibialis anterior muscle..Manipulating until achieving a "de Qi" sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is 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 treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days. Received routine antiemetic treatment. arm 3: Choose both Zusanli(ST36) and Zhongwan（CV12）.Manipulating until achieving a "de Qi" sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is 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 treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days. Received routine antiemetic treatment. arm 4: The control group will receive standard antiemetics alone. Standard antiemetics for all groups are 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 chemtherapy,and lasting for 3-5days. If nausea and/or vomiting is persistent and failed to respond to the antiemetic treatment , based on the experience of each clinician, the other advanced 5-HT3 antagonist or a neurokinin 1 antagonist(NK-1) will be chosen.
Interventions: intervention 1: single point Zhongwan(CV12) plus antiemetic drug intervention 2: single point Zusanli(ST36) plus antiemetic drug intervention 3: Zusanli(ST36)and Zhongwan(CV12) plus antiemetic drug intervention 4: only antiemetic drug
Intervention descriptions: intervention 1: All participants were supine in the hospital bed. A disposable sterile acupuncture needle (ø 0.30 × 40 mm, Hwato) was inserted vertically at approximately 20-30 mm until "De Qi" (sensation of soreness, numbness, distension, etc. around the acupoint) was reported by the participants. Then, the needle handle was clamped via a metal clip to connect to the positive electrode of the electric acupuncture apparatus (Huatuo, SDZ-V model, Suzhou Medical Appliance). Another reference electrode was placed 1 cm above the CV12 acupoints of the stimulation point, where no acupoints or meridians passed through. A dilatational wave at a frequency of 2/10 Hz and a current intensity at the highest level tolerated by the patient, with a maximum intensity no more than 10 mA, were used to deliver the EA stimulation. People in the intervention groups were offered a standardized 30-minute EA session once daily from the 1st day of the four-day chemotherapy cycle. intervention 2: A disposable sterile acupuncture needle (ø 0.30 × 40 mm, Hwato) was inserted vertically at approximately 20-30 mm until "De Qi" (sensation of soreness, numbness, distension, etc. around the acupoint) was reported by the participants. Then, the needle handle was clamped via a metal clip to connect to the positive electrode of the electric acupuncture apparatus (Huatuo, SDZ-V model, Suzhou Medical Appliance). Another reference electrode was placed 1cm below ST36 acupoints of the stimulation point, respectively, where no acupoints or meridians passed through. A dilatational wave at a frequency of 2/10 Hz and a current intensity at the highest level tolerated by the patient, with a maximum intensity no more than 10 mA, were used to deliver the EA stimulation. People in the intervention groups were offered a standardized 30-minute EA session once daily from the 1st day of the four-day chemotherapy cycle. intervention 3: Stimulating both Zusanli(ST36)and Zhongwan(CV12) intervention 4: received routine antiemetic treatment

Protocol documents: