Clinical Trial on Acupuncture Therapy in Patients With Gastrointestinal Neoplasms Laparoscopic Surgery

Gastrointestinal Neoplasms Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02871245
• Other study ID #: LCKY2016-38
• Status: Recruiting
• Phase: N/A
• First received: August 7, 2016
• Last updated: April 13, 2017
• Start date: September 21, 2016
• Est. completion date: July 2017

Study information

• Verified date: April 2017
• Source: The First Affiliated Hospital of Dalian Medical University
• Contact: Xiaonan Cui, MD, PhD
• Phone: +8618098876725
• Email: cxn23[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients accepted laparoscopic radical operation for carcinoma of colon and upper middle section of the rectum will be as the research object. Cancer patients are diagnosed based on pathology or cell biology. The trial is randomized, parallel and open. They are randomized into 2 groups: both groups receive surgery. The experimental group receives conventional treatment combine with electroacupuncture Zusanli point .etc finish operation and the contrast receives the same conventional treatment with experimental group. Clinical evaluation includes gastrointestinal tract recovery of function, pain relief, life quality improvement. Blood biochemistry tests mainly include gastrin(GAS), stress related hormone, peroxidatic reaction and the ratio of immune cells.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Weight: 40kg-90kg, male and female.

• Diagnosis: imaging, cell and pathology report.

• Brain, heart, lung, liver, kidney are at good condition in 2 weeks before surgery.

• No conscious obstacle and limbs disability.

Exclusion Criteria:

• Fainting during acupuncture.

• Electrolyte imbalance.

• Serious and life-threatening complications after surgery.

• In addition, 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.

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Neoplasms

Intervention

Procedure:
• Laparoscopic Surgery

Device:
• Acupuncture treatment

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Xiaonan Cui

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants and classification with operation-related adverse events as assessed by CTCAE v4.03.		day 1, day 3, day 5, day 7 after surgery
Secondary	The quality of life questionnaire(QLQ).	Assessing in 5 grade, mainly include appetite, sleep, pain,etc.	day 1, day 3, day 5, day 7 after surgery
Secondary	Stress hormone in blood.	Estradiol (female), progesterone (female), testosterone (male)	day 2, day 7 after surgery
Secondary	Immune cell number ratio in blood.	Th1/Th2, Th17/Treg	day 2, day 7 after surgery