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

Primary Purpose

Gastrointestinal Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Laparoscopic Surgery
Acupuncture treatment
Sponsored by
Xiaonan Cui
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Neoplasms focused on measuring Acupuncture Therapy, Laparoscopic Surgery, Gastrointestinal Tract Recovery of Function

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of Dalian Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Comparator Group

Acupuncture Therapy Group

Arm Description

Patients received gastrointestinal neoplasms laparoscopic surgery but no acupuncture therapy.

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

Outcomes

Primary Outcome Measures

Number of participants and classification with operation-related adverse events as assessed by CTCAE v4.03.

Secondary Outcome Measures

The quality of life questionnaire(QLQ).
Assessing in 5 grade, mainly include appetite, sleep, pain,etc.
Stress hormone in blood.
Estradiol (female), progesterone (female), testosterone (male)
Immune cell number ratio in blood.
Th1/Th2, Th17/Treg

Full Information

First Posted
August 7, 2016
Last Updated
April 13, 2017
Sponsor
Xiaonan Cui
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1. Study Identification

Unique Protocol Identification Number
NCT02871245
Brief Title
Clinical Trial on Acupuncture Therapy in Patients With Gastrointestinal Neoplasms Laparoscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 21, 2016 (Actual)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xiaonan Cui

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Neoplasms
Keywords
Acupuncture Therapy, Laparoscopic Surgery, Gastrointestinal Tract Recovery of Function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Comparator Group
Arm Type
Active Comparator
Arm Description
Patients received gastrointestinal neoplasms laparoscopic surgery but no acupuncture therapy.
Arm Title
Acupuncture Therapy Group
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Surgery
Intervention Type
Device
Intervention Name(s)
Acupuncture treatment
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
The quality of life questionnaire(QLQ).
Description
Assessing in 5 grade, mainly include appetite, sleep, pain,etc.
Time Frame
day 1, day 3, day 5, day 7 after surgery
Title
Stress hormone in blood.
Description
Estradiol (female), progesterone (female), testosterone (male)
Time Frame
day 2, day 7 after surgery
Title
Immune cell number ratio in blood.
Description
Th1/Th2, Th17/Treg
Time Frame
day 2, day 7 after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaonan Cui, MD, PhD
Phone
+8618098876725
Email
cxn23@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaonan Cui, MD, PhD
Organizational Affiliation
The First Affiliated Hospital of Dalian Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaonan Cui, MD, PhD
Phone
+8618098876725
Email
cxn23@sina.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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