BreastcancerPhase 3NCT02967146
Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®) After Axillary Dissection for Breast Cancer
A Phase 3 study testing adhesive barrier in people with Breastcancer and Surgery: Axillary Dissection, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Anti-adhesive effect and Safety of a mixed solid of poloxamer, gelatin and chitosan(Mediclore®) after axillary dissection for breast cancer Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Breastcancer, Surgery: Axillary Dissection
- What is being tested?
- adhesive barrier
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2016to Nov 2017
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the patients needed axillary dissection in breast cancer
- Written informed consent
- Patients without clinically significant lab
- the patients who are diagnosed 'positive for metastasis' by sentinel lymph node biopsy
Who cannot join
- having enrolled another clinical trials within 1 month
- Immunosuppression or autoimmune disease
- Anticoagulant, general steroids within a week from surgery
- Incompatible medications
- Serious diseases (heart failure, renal failure, liver failure, uncontrolled hypertension, diabetes mellitus, coagulation deficiencies)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
Sung Min Park, MD, +82-2-3410-3660, gs_sm.park@samsung.com
About this study
Official title: Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®) After Axillary Dissection for Breast Cancer A Multicenter Double-blinded, Randomized Study
Anti-adhesive effect and Safety of a mixed solid of poloxamer, gelatin and chitosan(Mediclore®) after axillary dissection for breast cancer
Read the detailed description
A Multicenter Double-blinded, Randomized Study
- Conditions
- Breastcancer, Surgery: Axillary Dissection
- Being tested
- adhesive barrier
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adhesive barrierDevice
After having axillary dissection, investigator has to inject the mediclore on op site directly and suture the site.
| Study group | Role | What they receive |
|---|---|---|
| Mediclore | Experimental | Not described Receives: Device: adhesive barrier |
| Not done | No intervention | Standard treatment for surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
sum of ROM(range of motion)
to compare the differences of sum of ROM between two groups comparision of the differences of sum of ROM between two groups ROM: forward flexion and horizontal abduction
Measured: 4weeks
Secondary outcomes (3)
sum of ROM(range of motion)
comparision of the differences of sum of ROM between two groups ROM: forward flexion and horizontal abduction
Measured: 24weeks
pain assessment (numeric pain rating scale)
to compare the differences of the pain related with motions of upper limbs
Measured: 4weeks, 24weeks
Scoring DASH(Disablities of the arm, shoulder and hand)
to compare the differences of the DASH score
Measured: 4weeks, 24weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastcancerStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seok Won Kim, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02967146
- Sponsor's protocol ID
- 2016-08-194-002
- Status last verified
- Jan 2017
- First submitted
- 16 Nov 2016
- Last updated
- 5 Jan 2017
- Results posted
- No
Publications
Choi HJ, Ryu JM, Chae BJ, Kim EK, Min JW, Shin HJ, Nam SJ, Yu J, Lee JE, Lee SK, Kim SW. Effect of Poloxamer-Based Thermo-Sensitive Sol-Gel Agent on Upper Limb Dysfunction after Axillary Lymph Node Dissection: A Double-Blind Randomized Clinical Trial. J Breast Cancer. 2021 Aug;24(4):367-376. doi: 10.4048/jbc.2021.24.e30. Epub 2021 Jun 17.
PubMed 34352935
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®) After Axillary Dissection for Breast Cancer A Multicenter Double-blinded, Randomized Study
- ClinicalTrials.gov ID
- NCT02967146
- Acronym / sponsor ID
- 2016-08-194-002
- Conditions
- Breastcancer, Surgery: Axillary Dissection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Nov 2017 (estimated)
- First posted
- 18 Nov 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.
Anti-adhesive effect and Safety of a mixed solid of poloxamer, gelatin and chitosan(Mediclore®) after axillary dissection for breast cancer
Detailed description
A Multicenter Double-blinded, Randomized Study
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mediclore | Experimental | Device: adhesive barrier |
| Not done | No intervention | –Standard treatment for surgery |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- the patients needed axillary dissection in breast cancer
- Written informed consent
- Patients without clinically significant lab
- the patients who are diagnosed 'positive for metastasis' by sentinel lymph node biopsy
Key exclusion criteria (5 listed)
- having enrolled another clinical trials within 1 month
- Immunosuppression or autoimmune disease
- Anticoagulant, general steroids within a week from surgery
- Incompatible medications
- Serious diseases (heart failure, renal failure, liver failure, uncontrolled hypertension, diabetes mellitus, coagulation deficiencies)
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 |
|---|---|---|
| adhesive barrierAfter having axillary dissection, investigator has to inject the mediclore on op site directly and suture the site. | Device | Mediclore |
Primary outcome
sum of ROM(range of motion)
Time frame: 4weeks
to compare the differences of sum of ROM between two groups comparision of the differences of sum of ROM between two groups ROM: forward flexion and horizontal abduction
3 secondary outcomes
sum of ROM(range of motion)
Time frame: 24weeks
pain assessment (numeric pain rating scale)
Time frame: 4weeks, 24weeks
Scoring DASH(Disablities of the arm, shoulder and hand)
Time frame: 4weeks, 24weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2017.
- Derived from this study: PubMed 34352935Choi HJ, Ryu JM, Chae BJ, Kim EK, Min JW, Shin HJ, Nam SJ, Yu J, Lee JE, Lee SK, Kim SW. Effect of Poloxamer-Based Thermo-Sensitive Sol-Gel Agent on Upper Limb Dysfunction after Axillary Lymph Node Dissection: A Double-Blind Randomized Clinical Trial. J Breast Cancer. 2021 Aug;24(4):367-376. doi: 10.4048/jbc.2021.24.e30. Epub 2021 Jun 17.
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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 adhesive barrier in people with Breastcancer and Surgery: Axillary Dissection, 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 4 inclusion and 5 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 5 Jan 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 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 Seok won Kim, MD (+82-2-3410-2375, seokwon1.kim@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sum of ROM(range of motion) (time frame: 4weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02967146, which also lists 1 linked publication.
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 5 Jan 2017.