Gastrointestinal CarcinomaNCT02871999
Clinical Trial on Acupuncture Adjuvant Treatment in the Pain After the Surgery of Gastrointestinal Carcinoma
A study testing Acupuncture therapy and Laparoscopic Surgery in people with Gastrointestinal Carcinoma and Pain, run by Xiaonan Cui.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastrointestinal Carcinoma, Pain
- What is being tested?
- Acupuncture therapy and Laparoscopic Surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to 1 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
- Conditions
- Gastrointestinal Carcinoma, Pain
- Being tested
- Acupuncture therapy, Laparoscopic Surgery
- Keywords
- Acupuncture Therapy, Pain degree after surgery
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture therapyDevice
Laparoscopic SurgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | This group receives normal treatment after surgery,with no acupuncture. Receives: 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. Receives: Device: Acupuncture therapy; Procedure: Laparoscopic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain degree change after surgery, Graded according to Numerical Rating Scale(NRS)
Measured: 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
Measured: day 1, day 2, day 3, day 4, day 5, day 6, day 7 after surgery
Prostaglandin E2(PGE2) in blood
Measured: day 2,day 7 after surgery
Estradiol(Female) in blood
Measured: day 2, day 7 after surgery
Th1/Th2 in blood
Measured: day 2, day 7 after surgery
5-Hydroxytryptamine(5-HT) in blood
Measured: day 2,day 7 after surgery
Histamine(HIS) in blood
Measured: day 2,day 7 after surgery
Th17/Treg in blood
Measured: day 2, day 7 after surgery
Testosterone(Male) in blood
Measured: day 2,day 7 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionJan 2019
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiaonan Cui
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaonan Cui, The First Affiliated Hospital of Dalian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871999
- Sponsor's protocol ID
- LCKY2016-39
- Status last verified
- Jan 2019
- First submitted
- 3 Aug 2016
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial on Acupuncture Adjuvant Treatment in the Pain After the Surgery of Gastrointestinal Carcinoma
- ClinicalTrials.gov ID
- NCT02871999
- Acronym / sponsor ID
- LCKY2016-39
- Conditions
- Gastrointestinal Carcinoma, Pain
- Keywords
- Acupuncture Therapy, Pain degree after surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Xiaonan CuiUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 18 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: Laparoscopic SurgeryThis group receives normal treatment after surgery,with no acupuncture. |
| Experimental group | Experimental | Device: Acupuncture therapy, Procedure: Laparoscopic SurgeryThis 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture therapy | Device | Experimental group |
| Laparoscopic Surgery | Procedure or surgery | Control group, Experimental group |
Primary outcome
Pain degree change after surgery, Graded according to Numerical Rating Scale(NRS)
Time frame: day 1, day 2, day 3, day 4, day 5, day 6, day 7 after surgery
8 secondary outcomes
Assessing the quality of life(QOL) change in 4 grades and recording: appetite, mental state, sleep, fatigue, attitude towards treatment, daily life ability
Time frame: day 1, day 2, day 3, day 4, day 5, day 6, day 7 after surgery
Prostaglandin E2(PGE2) in blood
Time frame: day 2,day 7 after surgery
Estradiol(Female) in blood
Time frame: day 2, day 7 after surgery
Th1/Th2 in blood
Time frame: day 2, day 7 after surgery
5-Hydroxytryptamine(5-HT) in blood
Time frame: day 2,day 7 after surgery
Histamine(HIS) in blood
Time frame: day 2,day 7 after surgery
Th17/Treg in blood
Time frame: day 2, day 7 after surgery
Testosterone(Male) in blood
Time frame: day 2,day 7 after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture therapy and Laparoscopic Surgery in people with Gastrointestinal Carcinoma and Pain, run by Xiaonan Cui.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain degree change after surgery, Graded according to Numerical Rating Scale(NRS) (time frame: day 1, day 2, day 3, day 4, day 5, day 6, day 7 after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2019.