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NCT Number: NCT05663112

Is Breast Massage Necessary to Find Sentinel Lymph Node?

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.

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Key information

Conditions

Sentinel Lymph Node Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Celal Bayar University

Manisa, Yunusemre, 45030, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sentinel Lymph Node Biopsy

Procedure

Sentinel lymph node biopsy will be performed.

Breast massage

Procedure

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

Blue dye injection

Procedure

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

Primary outcomes

  1. Sentinel lymph node detection rate

    Time frame: 2 weeks

    Participants will be followed until the pathology report is finalized

Sponsors and collaborators

Lead sponsor

Manisa Celal Bayar University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 23, 2022
Registry last updated
Sep 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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