Is Breast Massage Necessary to Find Sentinel Lymph Node?

Not Applicable

Completed

• Conditions: Sentinel Lymph Node; Breast Cancer
• Interventions: Procedure: Sentinel lymph node biopsy; Procedure: Breast massage; Procedure: Blue dye injection

• Registration Number: NCT05663112
• Lead Sponsor: Celal Bayar University

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.

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 Timeline

• Study Start: 2021-12-06
• Study First Submitted: 2021-12-22
• Study First Submitted QC: 2022-12-22
• Study First Posted: 2022-12-23
• Primary Completion: 2023-07-06
• Study Completion: 2023-07-06
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-22
• Last Update Posted: 2023-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm with massage	Blue dye injection	5 ml of isosulfan blue will be injected into the subareolar region. 5-minutes massage will be applied. Drug: Isosulfan Blue 5 ml
Arm with massage	Sentinel lymph node biopsy	5 ml of isosulfan blue will be injected into the subareolar region. 5-minutes massage will be applied. Drug: Isosulfan Blue 5 ml
Arm with massage	Breast massage	5 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	Sentinel lymph node biopsy	5 ml of isosulfan blue will be injected into the subareolar region. No massage will be applied. Drug: Isosulfan Blue 5 ml
Arm without massage	Blue dye injection	5 ml of isosulfan blue will be injected into the subareolar region. No massage will be applied. Drug: Isosulfan Blue 5 ml

Primary Outcome Measures

Name	Time	Method
Sentinel lymph node detection rate	2 weeks	Participants will be followed until the pathology report is finalized

Trial Locations

Locations (1)

Celal Bayar University; 🇹🇷 Manisa, Yunusemre, Turkey