NCT02871999

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 18, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

January 25, 2019

Status Verified

January 1, 2019

Enrollment Period

2.4 years

First QC Date

August 3, 2016

Last Update Submit

January 24, 2019

Conditions

Gastrointestinal CarcinomaPain

Keywords

Acupuncture TherapyPain degree after surgery

Outcome Measures

Primary Outcomes (1)

  • Pain degree change after surgery, Graded according to Numerical Rating Scale(NRS)

    day 1, day 2, day 3, day 4, day 5, day 6, day 7 after surgery

Secondary Outcomes (8)

  • Assessing the quality of life(QOL) change in 4 grades and recording: appetite, mental state, sleep, fatigue, attitude towards treatment, daily life ability

    day 1, day 2, day 3, day 4, day 5, day 6, day 7 after surgery

  • Prostaglandin E2(PGE2) in blood

    day 2,day 7 after surgery

  • Estradiol(Female) in blood

    day 2, day 7 after surgery

  • Th1/Th2 in blood

    day 2, day 7 after surgery

  • 5-Hydroxytryptamine(5-HT) in blood

    day 2,day 7 after surgery

  • +3 more secondary outcomes

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Procedure: Laparoscopic Surgery

Experimental group

EXPERIMENTAL

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.

Device: Acupuncture therapyProcedure: Laparoscopic Surgery

Interventions

Acupuncture therapyDEVICE
Experimental group
Laparoscopic SurgeryPROCEDURE
Control groupExperimental group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • General anesthesia,Gastric and Colorectal Cancer surgery under Laparoscopic;
  • Pathology diagnosed;
  • Brain, heart, lung, liver, kidney are at good condition before surgery;
  • No mental disorder, no conscious obstacle, no limbs disability.

You may not qualify if:

  • Severely complication after surgery;
  • Contraindication of the acupuncture;
  • Patients with mental disease;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Interventions

Acupuncture TherapyLaparoscopy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsEndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Chief Physician

Study Record Dates

First Submitted

August 3, 2016

First Posted

August 18, 2016

Study Start

August 1, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

January 25, 2019

Record last verified: 2019-01