Is Breast Massage Necessary to Find Sentinel Lymph Node?

NCT05663112 | Completed

• 1 other identifier: 20.478.486
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sentinel Lymph Node; Breast Cancer

Keywords

breast cancer; isosulfan blue; massage; sentinel lymph node; sentinel lymph node biopsy

Outcome Measures

Primary Outcomes (1)

• Sentinel lymph node detection rate

  Participants will be followed until the pathology report is finalized

  2 weeks

Study Arms (2)

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

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

Procedure: Sentinel lymph node biopsy; Procedure: Blue dye injection

Interventions

Sentinel lymph node biopsy PROCEDURE

Sentinel lymph node biopsy will be performed.

Arm with massage; Arm without massage

Breast massage PROCEDURE

Breast massage will be performed for a duration of 5 minutes.

Arm with massage

Blue dye injection PROCEDURE

Isosulfan blue dye will be injected in the subareolar region of the breast

Arm with massage; Arm without massage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• the diagnosis of breast cancer by biopsy
• participants voluntarily participated in the clinical trial and signed informed consent

You may not qualify if:

• had previous sentinel lymph node biopsy or axillary surgery
• had neoadjuvant chemotherapy
• had clinical hints of axillary lymph node metastasis

Sponsors & Collaborators

• Celal Bayar University: lead

Study Sites (1)

Celal Bayar University

Manisa, Yunusemre, 45030, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 14965682 RESULT

• 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.

  PMID: 11192930 RESULT

• 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.

  PMID: 15614159 RESULT

Related 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

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques

Study Officials

• Teoman Coskun, Prof.

  Celal Bayar University Department of General Surgery

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: not necessary
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant, MD

Model Details: 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 Record Dates

• First Submitted: December 22, 2021
• First Posted: December 23, 2022
• Study Start: December 6, 2021
• Primary Completion: July 6, 2023
• Study Completion: July 6, 2023
• Last Updated: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)