Sentinel Lymph NodeNCT05663112
Is Breast Massage Necessary to Find Sentinel Lymph Node?
A study testing Sentinel lymph node biopsy, Breast massage and Blue dye injection in people with Sentinel Lymph Node and Breast Cancer, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
Trial summary
Sentinel lymph node biopsy is important for staging in patients with breast cancer and changes the way of surgery. One of the most commonly used methods to find the sentinel lymph node during surgery is to apply blue dye around the areola and then search for the sentinel lymph node. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sentinel Lymph Node, Breast Cancer
- What is being tested?
- Sentinel lymph node biopsy, Breast massage and Blue dye injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Dec 2021to 6 Jul 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the diagnosis of breast cancer by biopsy
- participants voluntarily participated in the clinical trial and signed informed consent
Who cannot join
- had previous sentinel lymph node biopsy or axillary surgery
- had neoadjuvant chemotherapy
- had clinical hints of axillary lymph node metastasis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Celal Bayar University
Manisa, Yunusemre, 45030
About this study
Official title: Is Breast Massage Necessary to Find Sentinel Lymph Node After Isosulfan Blue Injection in Patients With Breast Cancer? A Prospective Randomized Study.
Sentinel lymph node biopsy is important for staging in patients with breast cancer and changes the way of surgery. One of the most commonly used methods to find the sentinel lymph node during surgery is to apply blue dye around the areola and then search for the sentinel lymph node. Breast massage is recommended following administration of the blue dye. However, the necessity of this massage is controversial. In this study, investigators will try to find out whether massage of the breast after blue dye injection has any positive effect on finding the sentinel lymph node.
Read the detailed description
This research is a prospective randomized study. Patients will be randomized by number-drawing method. Patients with BMI>30 and age>65 will be equally distributed to the experimental and active comparator arms. Under general anesthesia patients will be injected with 5 ml of isosulfan blue into the subareolar region. In one group, breast massage will be applied for 5 minutes. In the other group no massage will be applied. Surgical team will wait for a duration of 5 minutes for the self distribution of the blue dye.
- Conditions
- Sentinel Lymph Node, Breast Cancer
- Being tested
- Sentinel lymph node biopsy, Breast massage, Blue dye injection
- Keywords
- breast cancer, isosulfan blue, massage, sentinel lymph node, sentinel lymph node biopsy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel lymph node biopsyProcedure or surgery
Sentinel lymph node biopsy will be performed.
Breast massageProcedure or surgery
Breast massage will be performed for a duration of 5 minutes.
Blue dye injectionProcedure or surgery
Isosulfan blue dye will be injected in the subareolar region of the breast
| Study group | Role | What they receive |
|---|---|---|
| Arm with massage | Active comparator | 5 ml of isosulfan blue will be injected into the subareolar region. 5-minutes massage will be applied.
Drug: Isosulfan Blue 5 ml Receives: Procedure: Sentinel lymph node biopsy; Procedure: Breast massage; Procedure: Blue dye injection |
| Arm without massage | Experimental | 5 ml of isosulfan blue will be injected into the subareolar region. No massage will be applied.
Drug: Isosulfan Blue 5 ml Receives: Procedure: Sentinel lymph node biopsy; Procedure: Blue dye injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sentinel lymph node detection rate
Participants will be followed until the pathology report is finalized
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start6 Dec 2021
- Primary completion6 Jul 2023
- Study completion6 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sentinel Lymph NodeStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This research is a prospective randomized study. Patients will be randomized by number-drawing method. Patients with BMI\>30 and age\>65 will be equally distributed to the experimental and active comparator arms. Under general anesthesia patients will be injected with 5 ml of isosulfan blue into the subareolar region. In one group, breast massage will be applied for 5 minutes. In the other group no massage will be applied. Surgical team will wait for a duration of 5 minutes for the self distribution of the blue dye.
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manisa Celal Bayar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sezgi Erel, Manisa Celal Bayar University
- Investigators
- Teoman Coskun, Prof., Study director, Celal Bayar University Department of General Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05663112
- Sponsor's protocol ID
- 20.478.486
- Status last verified
- Sep 2023
- First submitted
- 22 Dec 2021
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data sharing will not contribute to other researchers
Publications
Shenoy V, Ravichandran D, Ralphs DN. Is massage following dye injection necessary in sentinel node biopsy in breast cancer? Breast. 2002 Jun;11(3):273-4. doi: 10.1054/brst.2002.0415.
PubMed 14965682Bass SS, Cox CE, Salud CJ, Lyman GH, McCann C, Dupont E, Berman C, Reintgen DS. The effects of postinjection massage on the sensitivity of lymphatic mapping in breast cancer. J Am Coll Surg. 2001 Jan;192(1):9-16. doi: 10.1016/s1072-7515(00)00771-7.
PubMed 11192930Diaz NM, Vrcel V, Centeno BA, Muro-Cacho C. Modes of benign mechanical transport of breast epithelial cells to axillary lymph nodes. Adv Anat Pathol. 2005 Jan;12(1):7-9. doi: 10.1097/01.pap.0000151267.34438.a1.
PubMed 15614159
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Breast Massage Necessary to Find Sentinel Lymph Node After Isosulfan Blue Injection in Patients With Breast Cancer? A Prospective Randomized Study.
- ClinicalTrials.gov ID
- NCT05663112
- Acronym / sponsor ID
- 20.478.486
- Conditions
- Sentinel Lymph Node, Breast Cancer
- Keywords
- breast cancer, isosulfan blue, massage, sentinel lymph node, sentinel lymph node biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Manisa Celal Bayar UniversityUniversity, hospital or other
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 6 Jul 2023 (actual)
- Study completion
- 6 Jul 2023 (actual)
- First posted
- 23 Dec 2022 (actual)
- 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.
Sentinel lymph node biopsy is important for staging in patients with breast cancer and changes the way of surgery. One of the most commonly used methods to find the sentinel lymph node during surgery is to apply blue dye around the areola and then search for the sentinel lymph node. Breast massage is recommended following administration of the blue dye. However, the necessity of this massage is controversial. In this study, investigators will try to find out whether massage of the breast after blue dye injection has any positive effect on finding the sentinel lymph node.
Detailed description
This research is a prospective randomized study. Patients will be randomized by number-drawing method. Patients with BMI>30 and age>65 will be equally distributed to the experimental and active comparator arms. Under general anesthesia patients will be injected with 5 ml of isosulfan blue into the subareolar region. In one group, breast massage will be applied for 5 minutes. In the other group no massage will be applied. Surgical team will wait for a duration of 5 minutes for the self distribution of the blue dye.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This research is a prospective randomized study. Patients will be randomized by number-drawing method. Patients with BMI>30 and age>65 will be equally distributed to the experimental and active comparator arms. Under general anesthesia patients will be injected with 5 ml of isosulfan blue into the subareolar region. In one group, breast massage will be applied for 5 minutes. In the other group no massage will be applied. Surgical team will wait for a duration of 5 minutes for the self distribution of the blue dye.
| Arm | Type | Receives |
|---|---|---|
| Arm with massage | Active comparator | Procedure: Sentinel lymph node biopsy, Procedure: Breast massage, Procedure: Blue dye injection5 ml of isosulfan blue will be injected into the subareolar region. 5-minutes massage will be applied. Drug: Isosulfan Blue 5 ml |
| Arm without massage | Experimental | Procedure: Sentinel lymph node biopsy, Procedure: Blue dye injection5 ml of isosulfan blue will be injected into the subareolar region. No massage will be applied. Drug: Isosulfan Blue 5 ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- the diagnosis of breast cancer by biopsy
- participants voluntarily participated in the clinical trial and signed informed consent
Key exclusion criteria (3 listed)
- had previous sentinel lymph node biopsy or axillary surgery
- had neoadjuvant chemotherapy
- had clinical hints of axillary lymph node metastasis
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 |
|---|---|---|
| Sentinel lymph node biopsySentinel lymph node biopsy will be performed. | Procedure or surgery | Arm with massage, Arm without massage |
| Breast massageBreast massage will be performed for a duration of 5 minutes. | Procedure or surgery | Arm with massage |
| Blue dye injectionIsosulfan blue dye will be injected in the subareolar region of the breast | Procedure or surgery | Arm with massage, Arm without massage |
Primary outcome
Sentinel lymph node detection rate
Time frame: 2 weeks
Participants will be followed until the pathology report is finalized
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 25 Sep 2023.
- Results publication: PubMed 14965682Shenoy V, Ravichandran D, Ralphs DN. Is massage following dye injection necessary in sentinel node biopsy in breast cancer? Breast. 2002 Jun;11(3):273-4. doi: 10.1054/brst.2002.0415.
- Results publication: PubMed 11192930Bass SS, Cox CE, Salud CJ, Lyman GH, McCann C, Dupont E, Berman C, Reintgen DS. The effects of postinjection massage on the sensitivity of lymphatic mapping in breast cancer. J Am Coll Surg. 2001 Jan;192(1):9-16. doi: 10.1016/s1072-7515(00)00771-7.
- Results publication: PubMed 15614159Diaz NM, Vrcel V, Centeno BA, Muro-Cacho C. Modes of benign mechanical transport of breast epithelial cells to axillary lymph nodes. Adv Anat Pathol. 2005 Jan;12(1):7-9. doi: 10.1097/01.pap.0000151267.34438.a1.
- Is massage following dye injection necessary in sentinel node biopsy in breast cancer?Link provided by the sponsor.
- The Effects of Postinjection Massage on the Sensitivity of Lymphatic Mapping in Breast CancerLink provided by the sponsor.
- Modes of Benign Mechanical Transport of Breast Epithelial Cells to Axillary Lymph NodesLink provided by the sponsor.
- Individual participant dataSharing planned: No. individual participant data sharing will not contribute to other researchers
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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.
Teoman Coskun, Prof. study director
Celal Bayar University Department of General Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sentinel lymph node biopsy, Breast massage and Blue dye injection in people with Sentinel Lymph Node and Breast Cancer, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
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 2 inclusion and 3 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 25 Sep 2023. 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 Turkey (Türkiye). 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?
Sentinel lymph node detection rate (time frame: 2 weeks). 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 NCT05663112, which also lists 3 linked publications.
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 25 Sep 2023.