Is Breast Massage Necessary to Find Sentinel Lymph Node?

Study Overview
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Brief Summary
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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
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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.

Official Title
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Is Breast Massage Necessary to Find Sentinel Lymph Node After Isosulfan Blue Injection in Patients With Breast Cancer? A Prospective Randomized Study.

Conditions
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Sentinel Lymph Node, Breast Cancer

Intervention / Treatment
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* Procedure: Sentinel lymph node biopsy
* Procedure: Breast massage
* Procedure: Blue dye injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: the diagnosis of breast cancer by biopsy participants voluntarily participated in the clinical trial and signed informed consent Exclusion Criteria: had previous sentinel lymph node biopsy or axillary surgery had neoadjuvant chemotherapy had clinical hints of axillary lymph node metastasis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm with massage<br>5 ml of isosulfan blue will be injected into the subareolar region. 5-minutes massage will be applied. Drug: Isosulfan Blue 5 ml | Procedure: Sentinel lymph node biopsy<br>* Sentinel lymph node biopsy will be performed.<br>Procedure: Breast massage<br>* Breast massage will be performed for a duration of 5 minutes.<br>Procedure: Blue dye injection<br>* Isosulfan blue dye will be injected in the subareolar region of the breast<br>|
| Experimental: Arm without massage<br>5 ml of isosulfan blue will be injected into the subareolar region. No massage will be applied. Drug: Isosulfan Blue 5 ml | Procedure: Sentinel lymph node biopsy<br>* Sentinel lymph node biopsy will be performed.<br>Procedure: Blue dye injection<br>* Isosulfan blue dye will be injected in the subareolar region of the breast<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sentinel lymph node detection rate | Participants will be followed until the pathology report is finalized | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, isosulfan blue, massage, sentinel lymph node, sentinel lymph node biopsy