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

X

Xiaonan Cui

Status

Completed

Conditions

Pain
Gastrointestinal Carcinoma

Treatments

Device: Acupuncture therapy
Procedure: Laparoscopic Surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT02871999
LCKY2016-39

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Control group
Active Comparator group
Description:
This group receives normal treatment after surgery,with no acupuncture.
Treatment:
Procedure: Laparoscopic Surgery
Experimental group
Experimental group
Description:
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.
Treatment:
Device: Acupuncture therapy
Procedure: Laparoscopic Surgery

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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