Effects of Acupuncture Stimulation on Systemic Inflammation

Nonsmall Cell Lung Cancer Clinical Trial

Official title:

Effects of Acupuncture Stimulation on Systemic Inflammation in Patients Undergoing Video-assisted Thoracoscopic Lobectomy Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02951611
• Other study ID #: Acu20161023
• Status: Recruiting
• Phase: N/A
• First received: October 29, 2016
• Last updated: March 16, 2017
• Start date: November 2016
• Est. completion date: June 2017

Study information

• Verified date: October 2016
• Source: RenJi Hospital
• Contact: Jie Tian, PhD,MD
• Phone: 86-21-68383702
• Email: vaseline2001[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

60 ASA physical status I or II patients, aged 18-75 years old , scheduled for elective video-assisted thoracoscopic lobectomy surgery,will be randomized into 2 groups,with 30 patients in each group: 1. control group and 2. treatment group. Patients in treatment group will receive transcutaneous electrical acupoint stimulation(TEAS) during the surgery and at 6h and 24h after surgery. Patients in the control group received only TIVA general anesthesia and sham electrical stimulation. Serum from patients of both groups will be collected at before surgery, 1h and 25h after surgery, respectively. Serum levels of TNF-alpha, IL-1 beta, CXCL8, IFN gamma and IL-4 at different time points will be measured and compared between the two groups.

Description:

60 ASA physical status I or II patients, aged 18-75 years old , scheduled for elective video-assisted thoracoscopic lobectomy surgery,will be randomized into 2 groups,with 30 patients in each group: 1. control group, who will receive total intravenous anesthesia(TIVA) and sham stimulation; and 2. treatment group, who will receive (TIVA) and transcutaneous electrical acupoint stimulation(TEAS). Since 30 min before induction of anesthesia, patients in treatment group will be stimulated at the 4 acupoints , Houxi、Zhigou、Neiguan and Hegu on both sides by Han's Acupoint Nerve Stimulator(HANS) until the end of the operation. At 6h and 24h after surgery, patients in treatment group will receive TEAS again, for 30 min each time.The frequency was 2/100Hz,the stimulate intensity was the maximum current that could be tolerated when the patients were awake.The control group received only TIVA general anesthesia and sham electrical stimulation.Serum from patients of both groups will be collected at before surgery, 1h and 25h after surgery, respectively and serum levels of TNF-alpha, IL-1 beta, CXCL8, IFN gamma and IL-4 at different time points will be measured. The primary outcome measures are serum TNF-alpha and IL-1 beta levels at 25h after surgery. The secondary outcome measures include serum levels of TNF-alpha, IL-1 beta, CXCL8, Th1/Th2 ratio (by calculating IFN gamma/IL-4) at 1h post surgery and serum levels of CXCL8, Th1/Th2 ratio at 25h post surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients diagnosed Non-Small Cell Lung Carcinoma (NSCLC) and will have elective video-assisted thoracoscopic lobectomy surgery

• ASA grade 1-2

• BMI between 18 to 31 kg/m2

Exclusion Criteria:

• with a history of thoracic surgery

• Unwilling to receive transcutaneous electrical acupoint stimulation

• BMI = 32 kg/m2

• Infection or scars at the acupoints

• periphery nerve injury at the upper or lower limbs

• Severe liver, renal, brain or lung disease

• Drug abuse

• Patients who cannot coordinate with investigators, such as dysphasia,severe infectious disease and disturbance of consciousness

• Patients participating other trials

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Inflammation
• Nonsmall Cell Lung Cancer

Intervention

Procedure:
• Acupuncture stimulation
Transcutaneous electrical acupoint stimulation on SI3, SJ6, PC6 and LI4
• Sham stimulation
Put electrodes on SI3, SJ6, PC6 and LI4 without stimulation

Locations

Country	Name	City	State
China	Renji hospital, School of Medicine, Shanghai Jiaotong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum TNF-a level		at 25 hour after surgery
Primary	serum IL-1ß level		at 25 hour after surgery
Secondary	serum TNF-a level		at 1 hour after surgery
Secondary	serum IL-1ß level		at 1 hour after surgery
Secondary	serum CXCL8 level		at 1 hour after surgery
Secondary	serum CXCL8 level		at 25 hour after surgery
Secondary	serum Th1/Th2 ratio		at 1 hour after surgery
Secondary	serum Th1/Th2 ratio		at 25 hour after surgery