Is Breast Massage Necessary to Find Sentinel Lymph Node?

• Sponsor: Celal Bayar University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05663112
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 19.8
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sentinel Lymph Node; Breast Cancer	Procedure: Sentinel lymph node biopsy; Procedure: Breast massage; Procedure: Blue dye injection	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Masking Description: not necessary
• Primary Purpose: Diagnostic
• Official Title: Is Breast Massage Necessary to Find Sentinel Lymph Node After Isosulfan Blue Injection in Patients With Breast Cancer? A Prospective Randomized Study.
• Actual Study Start Date: Dec 6, 2021
• Anticipated Primary Completion Date: Jun 6, 2023
• Anticipated Study Completion Date: Aug 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Sentinel lymph node detection rate [2 weeks]

   Participants will be followed until the pathology report is finalized

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Celal Bayar University	Manisa	Yunusemre	Turkey	45030

Sponsors and Collaborators

• Celal Bayar University

Investigators

• Study Director: Teoman Coskun, Prof., Celal Bayar University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• 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

Publications

None provided.

• Responsible Party: Sezgi Erel, Research assistant, MD, Celal Bayar University
• ClinicalTrials.gov Identifier: NCT05663112
• Other Study ID Numbers: 20.478.486
• First Posted: Dec 23, 2022
• Last Update Posted: Dec 23, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sezgi Erel, Research assistant, MD, Celal Bayar University: breast cancer; isosulfan blue; massage; sentinel lymph node; sentinel lymph node biopsy
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Dec 23, 2022