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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02871245
Other study ID # LCKY2016-38
Secondary ID
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
Health authority
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.

Study Design


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
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