Breast CancerNCT02089178
Comparison of the Effect of Total Intravenous Anesthesia and Inhalation Anesthesia on Cancer Cell Cytotoxicity, Micrometastasis and Recurrence of Tumor in Patients Undergoing Breast Tumor Resection
A study testing intravenous anesthesia, inhalation anesthesia and propofol-remifentanil in people with Breast Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the effect of total intravenous anesthesia and inhalation anesthesia on cancer cell cytotoxicity, micrometastasis and recurrence of tumor in patients undergoing breast tumor resection. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- intravenous anesthesia, inhalation anesthesia and propofol-remifentanil
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2014to 30 Dec 2014
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient between 20 and 65 of age with ASA physical status Ⅰ-Ⅲ
- breast cancer patients with no sign of local invasion (adjacent organs) and distant metastasis revealed by imaging studies
- surgery performed by the same surgical team
Who cannot join
- ASA physical status Ⅳ
- hepatic and renal impairment
- diabetes or other endocrine disorders
- body mass index > 35 kg/m2
- immune disorders or immunosuppressive therapy
- steroid treatment in the last 6 months
- inflammation
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the effect of total intravenous anesthesia and inhalation anesthesia on cancer cell cytotoxicity, micrometastasis and recurrence of tumor in patients undergoing breast tumor resection. Using propofol-remifentanil in total intravenous anesthesia group and sevoflurane -remifentanil in inhalation anesthesia group.
- Conditions
- Breast Cancer
- Being tested
- intravenous anesthesia, inhalation anesthesia, propofol-remifentanil, sevoflurane-remifentanil
- Keywords
- total intravenous anesthesia, inhalation anesthesia, cancer cell cytotoxicity, breast tumor
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous anesthesiaProcedure or surgery
total intravenous anesthesia group: propofol-remifentanil
inhalation anesthesiaProcedure or surgery
inhalation anesthesia group: sevoflurane-remifentanil
propofol-remifentanilDrug
sevoflurane-remifentanilDrug
| Study group | Role | What they receive |
|---|---|---|
| intravenous | Experimental | the total intravenous anesthesia group Receives: Procedure: intravenous anesthesia; Drug: propofol-remifentanil |
| inhalation | Active comparator | the inhalation anesthesia group Receives: Procedure: inhalation anesthesia; Drug: sevoflurane-remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of NK cell
comparison of the effect of total intravenous anesthesia and inhalation anesthesia on cancer cell cytotoxicity
Measured: at 24 hour after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completion30 Dec 2014
- Study completion30 Dec 2014
Why it stopped: The study costed more than expected, so the investigators decided to end it.
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.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02089178
- Sponsor's protocol ID
- 4-2013-0937
- Status last verified
- Dec 2014
- First submitted
- 12 Mar 2014
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Total Intravenous Anesthesia and Inhalation Anesthesia on Cancer Cell Cytotoxicity, Micrometastasis and Recurrence of Tumor in Patients Undergoing Breast Tumor Resection
- ClinicalTrials.gov ID
- NCT02089178
- Acronym / sponsor ID
- 4-2013-0937
- Conditions
- Breast Cancer
- Keywords
- total intravenous anesthesia, inhalation anesthesia, cancer cell cytotoxicity, breast tumor
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study costed more than expected, so the investigators decided to end it.
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- 30 Dec 2014 (actual)
- Study completion
- 30 Dec 2014 (actual)
- First posted
- 17 Mar 2014 (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.
The purpose of this study is to compare the effect of total intravenous anesthesia and inhalation anesthesia on cancer cell cytotoxicity, micrometastasis and recurrence of tumor in patients undergoing breast tumor resection. Using propofol-remifentanil in total intravenous anesthesia group and sevoflurane -remifentanil in inhalation anesthesia group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intravenous | Experimental | Procedure: intravenous anesthesia, Drug: propofol-remifentanilthe total intravenous anesthesia group |
| inhalation | Active comparator | Procedure: inhalation anesthesia, Drug: sevoflurane-remifentanilthe inhalation anesthesia group |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient between 20 and 65 of age with ASA physical status Ⅰ-Ⅲ
- breast cancer patients with no sign of local invasion (adjacent organs) and distant metastasis revealed by imaging studies
- surgery performed by the same surgical team
Key exclusion criteria (7 listed)
- ASA physical status Ⅳ
- hepatic and renal impairment
- diabetes or other endocrine disorders
- body mass index > 35 kg/m2
- immune disorders or immunosuppressive therapy
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 |
|---|---|---|
| intravenous anesthesiatotal intravenous anesthesia group: propofol-remifentanil | Procedure or surgery | intravenous |
| inhalation anesthesiainhalation anesthesia group: sevoflurane-remifentanil | Procedure or surgery | inhalation |
| propofol-remifentanil | Drug | intravenous |
| sevoflurane-remifentanil | Drug | inhalation |
Primary outcome
number of NK cell
Time frame: at 24 hour after surgery.
comparison of the effect of total intravenous anesthesia and inhalation anesthesia on cancer cell cytotoxicity
Results and safety
The study was stopped early (reason given: The study costed more than expected, so the investigators decided to end it.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intravenous anesthesia, inhalation anesthesia and propofol-remifentanil in people with Breast Cancer, run by Yonsei University 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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 19 Mar 2019. 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 was stopped early (reason given: The study costed more than expected, so the investigators decided to end it.). Results are not available in the source record.
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?
number of NK cell (time frame: at 24 hour 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 19 Mar 2019.