Breast NeoplasmsPhase 3NCT02141139
Perioperative Inflammation and Breast Cancer Outcome
A Phase 3 study testing NSAIDS (ketorolac and ibuprofen) in people with Breast Neoplasms, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
It is increasingly recognized the NSAIDS (nonsteroidal antiinflammatory drug) might prevent the several cancers. In breast cancer, the role of NSAIDS (nonsteroidal antiinflammatory drug) has been suggested.However, there was no consistent results. surgery is main cause of inflammation for cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- NSAIDS (ketorolac and ibuprofen)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,568 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2014to Jan 2016
- Phase
- Phase 3
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer patients who took the surgery
Who cannot join
- underlying medical disease (major heart disease, lung disease, coagulopathy)
- major psychologic disease (major depression, schizophrenia, manic disorder)
- pregnancy
- rheumatic disease patients
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Samsung Medical Center
Seoul, 135-710
Se Kyung Lee, M.D., 82-10-3014-0110, sekyung.lee@samsung.com
About this study
Official title: Suppression of Inflammation by Using NSAIDs During Peri-operative Period Can Affect the Prognosis of Breast Cancer.
It is increasingly recognized the NSAIDS (nonsteroidal antiinflammatory drug) might prevent the several cancers. In breast cancer, the role of NSAIDS (nonsteroidal antiinflammatory drug) has been suggested.However, there was no consistent results. surgery is main cause of inflammation for cancer patients. Therefore, we want to know the association between prevention of perioperative inflammation with NSAIDS and breast cancer outcomes.
- Conditions
- Breast Neoplasms
- Being tested
- NSAIDS (ketorolac and ibuprofen)
- Keywords
- Anti-Inflammatory Agents, Non-Steroidal, Inflammation, Perioperative Period
- Medical subject headings
- Breast Neoplasms, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSAIDS (ketorolac and ibuprofen)Drug
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | no medication or acetaminophen |
| NSAIDS (ketorolac intravenous, ibuprofen) | Experimental | ketorolac IV (just before surgery) and ibuprofen for 1 weeks Receives: Drug: NSAIDS (ketorolac and ibuprofen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free survival
Measured: 5 years
Secondary outcomes (1)
overall survival
Measured: 5years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,568 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seok Jin Nam, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02141139
- Sponsor's protocol ID
- 2009-11-036
- Status last verified
- May 2014
- First submitted
- 21 Oct 2013
- Last updated
- 19 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suppression of Inflammation by Using NSAIDs During Peri-operative Period Can Affect the Prognosis of Breast Cancer.
- ClinicalTrials.gov ID
- NCT02141139
- Acronym / sponsor ID
- 2009-11-036
- Conditions
- Breast Neoplasms
- Keywords
- Anti-Inflammatory Agents, Non-Steroidal, Inflammation, Perioperative Period
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,568 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jan 2016 (estimated)
- First posted
- 19 May 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.
It is increasingly recognized the NSAIDS (nonsteroidal antiinflammatory drug) might prevent the several cancers. In breast cancer, the role of NSAIDS (nonsteroidal antiinflammatory drug) has been suggested.However, there was no consistent results. surgery is main cause of inflammation for cancer patients. Therefore, we want to know the association between prevention of perioperative inflammation with NSAIDS and breast cancer outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –no medication or acetaminophen |
| NSAIDS (ketorolac intravenous, ibuprofen) | Experimental | Drug: NSAIDS (ketorolac and ibuprofen)ketorolac IV (just before surgery) and ibuprofen for 1 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Breast cancer patients who took the surgery
Key exclusion criteria (4 listed)
- underlying medical disease (major heart disease, lung disease, coagulopathy)
- major psychologic disease (major depression, schizophrenia, manic disorder)
- pregnancy
- rheumatic disease patients
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 |
|---|---|---|
| NSAIDS (ketorolac and ibuprofen) | Drug | NSAIDS (ketorolac intravenous, ibuprofen) |
Primary outcome
disease free survival
Time frame: 5 years
1 secondary outcome
overall survival
Time frame: 5years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NSAIDS (ketorolac and ibuprofen) in people with Breast Neoplasms, run by Samsung 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: status not confirmed, as of the sponsor's last update on 19 May 2014. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Se Kyung Lee, M.D. (82-10-3014-0110, sekyung.lee@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease free survival (time frame: 5 years). 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 May 2014.