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

N/ACompletedNCT02871999

Xiaonan Cui60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gastrointestinal Carcinoma Pain

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Pain degree change after surgery, Graded according to Numerical Rating Scale(NRS)

Time frame: day 1, day 2, day 3, day 4, day 5, day 6, day 7 after surgery

Secondary Outcomes

Assessing the quality of life(QOL) change in 4 grades and recording: appetite, mental state, sleep, fatigue, attitude towards treatment, daily life ability

Time frame: day 1, day 2, day 3, day 4, day 5, day 6, day 7 after surgery

Prostaglandin E2(PGE2) in blood

Time frame: day 2,day 7 after surgery

Estradiol(Female) in blood

Time frame: day 2, day 7 after surgery

Th1/Th2 in blood

Time frame: day 2, day 7 after surgery

5-Hydroxytryptamine(5-HT) in blood

Time frame: day 2,day 7 after surgery

Histamine(HIS) in blood

Time frame: day 2,day 7 after surgery

Th17/Treg in blood

Time frame: day 2, day 7 after surgery

Testosterone(Male) in blood

Time frame: day 2,day 7 after surgery