Effects of Acupuncture Stimulation on Systemic Inflammation
Primary Purpose
Nonsmall Cell Lung Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Acupuncture stimulation
Sham stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Nonsmall Cell Lung Cancer
Eligibility Criteria
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
Sites / Locations
- Renji hospital, School of Medicine, Shanghai Jiaotong UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Sham stimulation
Treatment: Acupuncture stimulation
Arm Description
Put the electrodes on SI3, SJ6, PC6 and LI4 without stimulation.
Stimulate the SI3, SJ6, PC6 and LI4 since 30 minutes before anesthesia induction until the end of operation. Stimulate again at above acupoints at 6 and 24h after operation, for 30 minutes each time. The stimulation frequency is 2/100Hz. The stimulation current is two to three times of the lowest current that the patient can feel.
Outcomes
Primary Outcome Measures
serum TNF-α level
serum IL-1β level
Secondary Outcome Measures
serum TNF-α level
serum IL-1β level
serum CXCL8 level
serum CXCL8 level
serum Th1/Th2 ratio
serum Th1/Th2 ratio
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02951611
Brief Title
Effects of Acupuncture Stimulation on Systemic Inflammation
Official Title
Effects of Acupuncture Stimulation on Systemic Inflammation in Patients Undergoing Video-assisted Thoracoscopic Lobectomy Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital
4. Oversight
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonsmall Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
Put the electrodes on SI3, SJ6, PC6 and LI4 without stimulation.
Arm Title
Treatment: Acupuncture stimulation
Arm Type
Experimental
Arm Description
Stimulate the SI3, SJ6, PC6 and LI4 since 30 minutes before anesthesia induction until the end of operation. Stimulate again at above acupoints at 6 and 24h after operation, for 30 minutes each time. The stimulation frequency is 2/100Hz. The stimulation current is two to three times of the lowest current that the patient can feel.
Intervention Type
Procedure
Intervention Name(s)
Acupuncture stimulation
Intervention Description
Transcutaneous electrical acupoint stimulation on SI3, SJ6, PC6 and LI4
Intervention Type
Procedure
Intervention Name(s)
Sham stimulation
Intervention Description
Put electrodes on SI3, SJ6, PC6 and LI4 without stimulation
Primary Outcome Measure Information:
Title
serum TNF-α level
Time Frame
at 25 hour after surgery
Title
serum IL-1β level
Time Frame
at 25 hour after surgery
Secondary Outcome Measure Information:
Title
serum TNF-α level
Time Frame
at 1 hour after surgery
Title
serum IL-1β level
Time Frame
at 1 hour after surgery
Title
serum CXCL8 level
Time Frame
at 1 hour after surgery
Title
serum CXCL8 level
Time Frame
at 25 hour after surgery
Title
serum Th1/Th2 ratio
Time Frame
at 1 hour after surgery
Title
serum Th1/Th2 ratio
Time Frame
at 25 hour after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Tian, PhD,MD
Phone
86-21-68383702
Email
vaseline2001@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fan Zhang
Phone
86-21-68383702
Email
597158323@qq.com
Facility Information:
Facility Name
Renji hospital, School of Medicine, Shanghai Jiaotong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Tian, PhD,MD
Phone
0086-21-68383702
Email
vaseline2001@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effects of Acupuncture Stimulation on Systemic Inflammation
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