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

April 13, 2017 updated by: Xiaonan Cui
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xiaonan Cui, MD, PhD
  • Phone Number: +8618098876725
  • Email: cxn23@sina.com

Study Locations

  • China
    • Liaoning
      • Dalian, Liaoning, China, 116011
        • Recruiting
        • The First Affiliated Hospital of Dalian Medical University
        • Contact:
          • Xiaonan Cui, MD, PhD
          • Phone Number: +8618098876725
          • Email: cxn23@sina.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Comparator Group
Patients received gastrointestinal neoplasms laparoscopic surgery but no acupuncture therapy.
Procedure: Laparoscopic Surgery
Experimental: Acupuncture Therapy Group
Patients received gastrointestinal neoplasms laparoscopic surgery and acupuncture therapy. Finish surgery up to 24 hours electricity acupuncture treatment, treatment 1 times a day, every time lasted 30 minutes, 5 days in a row
Procedure: Laparoscopic Surgery
Device: Acupuncture treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants and classification with operation-related adverse events as assessed by CTCAE v4.03.
Time Frame: day 1, day 3, day 5, day 7 after surgery
day 1, day 3, day 5, day 7 after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The quality of life questionnaire(QLQ).
Time Frame: day 1, day 3, day 5, day 7 after surgery
Assessing in 5 grade, mainly include appetite, sleep, pain,etc.
day 1, day 3, day 5, day 7 after surgery
Stress hormone in blood.
Time Frame: day 2, day 7 after surgery
Estradiol (female), progesterone (female), testosterone (male)
day 2, day 7 after surgery
Immune cell number ratio in blood.
Time Frame: day 2, day 7 after surgery
Th1/Th2, Th17/Treg
day 2, day 7 after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiaonan Cui

Investigators

  • Principal Investigator: Xiaonan Cui, MD, PhD, The First Affiliated Hospital of Dalian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2016

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

August 7, 2016

First Submitted That Met QC Criteria

August 14, 2016

First Posted (Estimate)

August 18, 2016

Study Record Updates

Last Update Posted (Actual)

April 14, 2017

Last Update Submitted That Met QC Criteria

April 13, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCKY2016-38

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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