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

NCT ID: NCT02871999

Last Updated: 2019-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2019-01-01

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.

Conditions

Gastrointestinal Carcinoma; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

This group receives normal treatment after surgery,with no acupuncture.

Group Type: ACTIVE_COMPARATOR

Laparoscopic Surgery

Intervention Type: PROCEDURE

Experimental group

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.

Group Type: EXPERIMENTAL

Acupuncture therapy

Intervention Type: DEVICE

Laparoscopic Surgery

Intervention Type: PROCEDURE

Interventions

Acupuncture therapy

Intervention Type: DEVICE

Laparoscopic Surgery

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiaonan Cui

OTHER

Sponsor Role: lead

Responsible Party

Xiaonan Cui

Professor, Chief Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

LCKY2016-39

Identifier Type: -

Identifier Source: org_study_id