Clinical Trial on Acupuncture Adjuvant Treatment in the Pain After the Surgery of Gastrointestinal Carcinoma

Study Overview
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Brief Summary
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Clinical trial on acupuncture adjuvant treatment in the pain after the surgery of gastrointestinal carcinoma. Gastrointestinal cancer patients are diagnosed by pathology or cell biology. Patients are randomized into 2 groups: The control group receive normal treatment only, the experimental group receive acupuncture therapy besides normal treatment. Clinical evaluation is based on the observation of the pain degree and life quality improvement. Blood biochemistry tests mainly include Prostaglandin E2(PGE2),5-hydroxytryptamine(5-HT), histamine(HIS), malondialdehyde (MDA), superoxide dismutase (SOD), glutathione peroxidase (GSH-Px), adrenaline, nor-adrenaline, tumor necrosis factor (TNF)-α, cell flow cytometry on Th1, Th2, Th17, Treg cytokines as well as serum cortisol, estradiol (female), progesterone (female), testosterone (male) etc.

Conditions
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Gastrointestinal Carcinoma, Pain

Intervention / Treatment
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* Device: Acupuncture therapy
* Procedure: Laparoscopic Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General anesthesia,Gastric and Colorectal Cancer surgery under Laparoscopic; Pathology diagnosed; Brain, heart, lung, liver, kidney are at good condition before surgery; No mental disorder, no conscious obstacle, no limbs disability. Exclusion Criteria: Severely complication after surgery; Contraindication of the acupuncture; Patients with mental disease; Patients taking part in other clinical trials, being treated with other biotherapy or immunotherapy and researchers consider not suitable for clinical subjects for other reasons will be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>This group receives normal treatment after surgery,with no acupuncture. | Procedure: Laparoscopic Surgery<br> <br> |
| Experimental: Experimental group<br>This group receives acupuncture therapy besides normal treatment after surgery. The acupuncture therapy starts after 24 hours of surgery, 1 time a day, 30 minutes every time, until the fifth day. | Device: Acupuncture therapy<br> <br> Procedure: Laparoscopic Surgery<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain degree change after surgery, Graded according to Numerical Rating Scale(NRS) |  | day 1, day 2, day 3, day 4, day 5, day 6, day 7 after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing the quality of life(QOL) change in 4 grades and recording: appetite, mental state, sleep, fatigue, attitude towards treatment, daily life ability |  | day 1, day 2, day 3, day 4, day 5, day 6, day 7 after surgery | 
| Prostaglandin E2(PGE2) in blood |  | day 2,day 7 after surgery | 
| Estradiol(Female) in blood |  | day 2, day 7 after surgery | 
| Th1/Th2 in blood |  | day 2, day 7 after surgery | 
| 5-Hydroxytryptamine(5-HT) in blood |  | day 2,day 7 after surgery | 
| Histamine(HIS) in blood |  | day 2,day 7 after surgery | 
| Th17/Treg in blood |  | day 2, day 7 after surgery | 
| Testosterone(Male) in blood |  | day 2,day 7 after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture Therapy, Pain degree after surgery