Is Breast Massage Necessary to Find Sentinel Lymph Node?

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05663112
• Other study ID #: 20.478.486
• Status: Completed
• Phase: N/A
• Start date: December 6, 2021
• Est. completion date: July 6, 2023

Study information

• Verified date: September 2023
• Source: Celal Bayar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: July 6, 2023
• Est. primary completion date: July 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Sentinel Lymph Node

Intervention

Procedure:
• Sentinel lymph node biopsy
Sentinel lymph node biopsy will be performed.
• Breast massage
Breast massage will be performed for a duration of 5 minutes.
• Blue dye injection
Isosulfan blue dye will be injected in the subareolar region of the breast

Locations

Country	Name	City	State
Turkey	Celal Bayar University	Manisa	Yunusemre

Sponsors (1)

Lead Sponsor	Collaborator
Celal Bayar University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sentinel lymph node detection rate	Participants will be followed until the pathology report is finalized	2 weeks

External Links

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