Is Breast Massage Necessary to Find Sentinel Lymph Node?

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Sentinel Lymph Node
• Intervention / Treatment: Procedure: Sentinel lymph node biopsy; Procedure: Breast massage; Procedure: Blue dye injection

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 Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Yunusemre
    • Manisa, Yunusemre, Turkey, 45030
      • Celal Bayar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm with massage; 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; Sentinel lymph node biopsy will be performed.; Procedure: Breast massage; Breast massage will be performed for a duration of 5 minutes.; Procedure: Blue dye injection; Isosulfan blue dye will be injected in the subareolar region of the breast
Experimental: Arm without massage; 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; Sentinel lymph node biopsy will be performed.; Procedure: Blue dye injection; Isosulfan blue dye will be injected in the subareolar region of the breast

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Celal Bayar University
• Investigators: Study Director: Teoman Coskun, Prof., Celal Bayar University Department of General Surgery

Publications and helpful links

General 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.
• Bass 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.
• Diaz 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.

Helpful Links

• Is massage following dye injection necessary in sentinel node biopsy in breast cancer?
• The Effects of Postinjection Massage on the Sensitivity of Lymphatic Mapping in Breast Cancer
• Modes of Benign Mechanical Transport of Breast Epithelial Cells to Axillary Lymph Nodes

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2021
• Primary Completion (Actual): July 6, 2023
• Study Completion (Actual): July 6, 2023

Study Registration Dates

• First Submitted: December 22, 2021
• First Submitted That Met QC Criteria: December 22, 2022
• First Posted (Actual): December 23, 2022

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: breast cancer; sentinel lymph node; massage; sentinel lymph node biopsy; isosulfan blue
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 20.478.486

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: individual participant data sharing will not contribute to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No