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

Not Applicable

Completed

• Conditions: Pain; Gastrointestinal Carcinoma
• Interventions: Procedure: Laparoscopic Surgery; Device: Acupuncture therapy

• Registration Number: NCT02871999
• Lead Sponsor: Xiaonan Cui

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-03
• Study First Submitted QC: 2016-08-15
• Study First Posted: 2016-08-18
• Status Verified: 2019-01
• Primary Completion: 2019-01
• Study Completion: 2019-01-01
• Last Update Submitted: 2019-01-24
• Last Update Posted: 2019-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. General anesthesia,Gastric and Colorectal Cancer surgery under Laparoscopic;
2. Pathology diagnosed;
3. Brain, heart, lung, liver, kidney are at good condition before surgery;
4. No mental disorder, no conscious obstacle, no limbs disability.

Exclusion Criteria

1. Severely complication after surgery;
2. Contraindication of the acupuncture;
3. Patients with mental disease;
4. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Laparoscopic Surgery	This group receives normal treatment after surgery,with no acupuncture.
Experimental group	Laparoscopic Surgery	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.
Experimental group	Acupuncture therapy	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Th17/Treg in blood	day 2, day 7 after surgery
Estradiol(Female) in blood	day 2, day 7 after surgery
5-Hydroxytryptamine(5-HT) in blood	day 2,day 7 after surgery
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
Histamine(HIS) in blood	day 2,day 7 after surgery
Testosterone(Male) in blood	day 2,day 7 after surgery
Th1/Th2 in blood	day 2, day 7 after surgery