Gastrointestinal NeoplasmsNCT02871245
Clinical Trial on Acupuncture Therapy in Patients With Gastrointestinal Neoplasms Laparoscopic Surgery
A study testing Laparoscopic Surgery and Acupuncture treatment in people with Gastrointestinal Neoplasms, run by Xiaonan Cui at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastrointestinal Neoplasms
- What is being tested?
- Laparoscopic Surgery and Acupuncture treatment
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 21 Sep 2016to Jul 2017
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011
Xiaonan Cui, MD, PhD, +8618098876725, cxn23@sina.com
About this study
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.
- Conditions
- Gastrointestinal Neoplasms
- Being tested
- Laparoscopic Surgery, Acupuncture treatment
- Keywords
- Acupuncture Therapy, Laparoscopic Surgery, Gastrointestinal Tract Recovery of Function
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic SurgeryProcedure or surgery
Acupuncture treatmentDevice
| Study group | Role | What they receive |
|---|---|---|
| Comparator Group | Active comparator | Patients received gastrointestinal neoplasms laparoscopic surgery but no acupuncture therapy. Receives: Procedure: Laparoscopic Surgery |
| Acupuncture Therapy Group | Experimental | 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 Receives: Procedure: Laparoscopic Surgery; Device: Acupuncture treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants and classification with operation-related adverse events as assessed by CTCAE v4.03.
Measured: day 1, day 3, day 5, day 7 after surgery
Secondary outcomes (3)
The quality of life questionnaire(QLQ).
Assessing in 5 grade, mainly include appetite, sleep, pain,etc.
Measured: day 1, day 3, day 5, day 7 after surgery
Stress hormone in blood.
Estradiol (female), progesterone (female), testosterone (male)
Measured: day 2, day 7 after surgery
Immune cell number ratio in blood.
Th1/Th2, Th17/Treg
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 start21 Sep 2016
- Primary completionMay 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal NeoplasmsStudies 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
- 120 participants (estimated)
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
- Investigators
- Xiaonan Cui, MD, PhD, Principal investigator, The First Affiliated Hospital of Dalian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871245
- Sponsor's protocol ID
- LCKY2016-38
- Status last verified
- Apr 2017
- First submitted
- 7 Aug 2016
- Last updated
- 14 Apr 2017
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial on Acupuncture Therapy in Patients With Gastrointestinal Neoplasms Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT02871245
- Acronym / sponsor ID
- LCKY2016-38
- Conditions
- Gastrointestinal Neoplasms
- Keywords
- Acupuncture Therapy, Laparoscopic Surgery, Gastrointestinal Tract Recovery of Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Xiaonan CuiUniversity, hospital or other
- Study start
- 21 Sep 2016 (actual)
- Primary completion
- May 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparator Group | Active comparator | Procedure: Laparoscopic SurgeryPatients received gastrointestinal neoplasms laparoscopic surgery but no acupuncture therapy. |
| Acupuncture Therapy Group | Experimental | Procedure: Laparoscopic Surgery, Device: Acupuncture treatmentPatients 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Laparoscopic Surgery | Procedure or surgery | Acupuncture Therapy Group, Comparator Group |
| Acupuncture treatment | Device | Acupuncture Therapy Group |
Primary outcome
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
3 secondary outcomes
The quality of life questionnaire(QLQ).
Time frame: day 1, day 3, day 5, day 7 after surgery
Stress hormone in blood.
Time frame: day 2, day 7 after surgery
Immune cell number ratio in blood.
Time frame: day 2, day 7 after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
- 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.
Xiaonan Cui, MD, PhD principal investigator
The First Affiliated Hospital of Dalian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Surgery and Acupuncture treatment in people with Gastrointestinal Neoplasms, run by Xiaonan Cui at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaonan Cui, MD, PhD (+8618098876725, cxn23@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 14 Apr 2017.