Breast CancerNCT02567929
Assessment of the Anesthetic Effect on the Activity of Immune Cell in Patient With Breast Cancer
A study testing propofol group and sevoflurane group in people with Breast Cancer, run by Konkuk University Medical Center at 1 site in South Korea.
Trial summary
Anesthetics agents has variety inflammation during the cancer surgery. This perioperative inflammation can influence to cancer metastasis or recurrence. The purpose of this study is to prove the variation of immune cell activity between preoperative and postoperative period. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- propofol group and sevoflurane group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2016to Dec 2016
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient who was planned to undergo colon cancer surgery.
Who cannot join
- age < 20 years old
- history of hypersensitivity reaction in propofol or sevoflurane
- history of previous cancer
- patient with ongoing inflammation
Trial locations and contacts
1 site in 1 country.
About this study
Anesthetics agents has variety inflammation during the cancer surgery. This perioperative inflammation can influence to cancer metastasis or recurrence.
The purpose of this study is to prove the variation of immune cell activity between preoperative and postoperative period.
Read the detailed description
The patients were allocated randomly to receive propofol or sevoflurane. Also, a total of 18ml of blood sample was obtained for total 3 times in consecutive order.
- immediate before anesthesia induction
- postoperative 1 hours
- postoperative 24 hours
Serum in blood will be obtained and activity of helper T cell, natural killer cell and level of serum cytokine will be evaluated by flow cytometry or enzyme-linked immunosorbent assay
- Conditions
- Breast Cancer
- Being tested
- propofol group, sevoflurane group
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofol groupDrug
Also called propofol
Patient will be anesthetized by using propofol infusion during operation.
sevoflurane groupDrug
Also called sevoflurane
Patient will be anesthetized by using sevoflurane inhalation during operation.
| Study group | Role | What they receive |
|---|---|---|
| propofol group | Active comparator | The patient who anesthetized by using propofol. Receives: Drug: propofol group |
| sevoflurane group | Active comparator | The patient who anesthetized by using propofol Receives: Drug: sevoflurane group |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD39 and CD73 on circulating regualtory T cells
change of percentage of CD39 and CD73 (scores range from 0 to 100)
Measured: preoperative time. postoperative 1 hours and 24 hours
Secondary outcomes (1)
Circulating natural killer cells
change of percentage of circulating natural killer cell (scores range from 0 to 100)
Measured: preoperative time. postoperative 1 hours and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study startMar 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seong-Hyop Kim, Konkuk University Medical Center
- Investigators
- Seong-Hyop Kim, M.D,Ph.D, Principal investigator, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567929
- Sponsor's protocol ID
- KUH1160086
- Status last verified
- Mar 2018
- First submitted
- 2 Sep 2015
- Last updated
- 2 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Anesthetic Effect on the Activity of Immune Cell in Patient With Breast Cancer
- ClinicalTrials.gov ID
- NCT02567929
- Acronym / sponsor ID
- KUH1160086
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 5 Oct 2015 (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.
Anesthetics agents has variety inflammation during the cancer surgery. This perioperative inflammation can influence to cancer metastasis or recurrence.
The purpose of this study is to prove the variation of immune cell activity between preoperative and postoperative period.
Detailed description
The patients were allocated randomly to receive propofol or sevoflurane. Also, a total of 18ml of blood sample was obtained for total 3 times in consecutive order.
- immediate before anesthesia induction
- postoperative 1 hours
- postoperative 24 hours
Serum in blood will be obtained and activity of helper T cell, natural killer cell and level of serum cytokine will be evaluated by flow cytometry or enzyme-linked immunosorbent assay
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol group | Active comparator | Drug: propofol groupThe patient who anesthetized by using propofol. |
| sevoflurane group | Active comparator | Drug: sevoflurane groupThe patient who anesthetized by using propofol |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient who was planned to undergo colon cancer surgery.
Key exclusion criteria (4 listed)
- age < 20 years old
- history of hypersensitivity reaction in propofol or sevoflurane
- history of previous cancer
- patient with ongoing inflammation
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 |
|---|---|---|
| propofol groupAlso: propofolPatient will be anesthetized by using propofol infusion during operation. | Drug | propofol group |
| sevoflurane groupAlso: sevofluranePatient will be anesthetized by using sevoflurane inhalation during operation. | Drug | sevoflurane group |
Primary outcome
CD39 and CD73 on circulating regualtory T cells
Time frame: preoperative time. postoperative 1 hours and 24 hours
change of percentage of CD39 and CD73 (scores range from 0 to 100)
1 secondary outcome
Circulating natural killer cells
Time frame: preoperative time. postoperative 1 hours and 24 hours
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 2 Apr 2018.
- Individual participant dataSharing planned: No
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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.
Seong-Hyop Kim, M.D,Ph.D principal investigator
Konkuk University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing propofol group and sevoflurane group in people with Breast Cancer, run by Konkuk University Medical Center at 1 site in South Korea.
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 1 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 2 Apr 2018. 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 South Korea. 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?
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?
CD39 and CD73 on circulating regualtory T cells (time frame: preoperative time. postoperative 1 hours and 24 hours). 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 2 Apr 2018.