Clinical trial NCT05663112: Is Breast Massage Necessary to Find Sentinel Lymph Node?
Official title: Is Breast Massage Necessary to Find Sentinel Lymph Node After Isosulfan Blue Injection in Patients With Breast Cancer? A Prospective Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sentinel Lymph Node
Breast Cancer
Keywords: breast cancer
isosulfan blue
massage
sentinel lymph node
sentinel lymph node biopsy
Lead sponsor: Celal Bayar University
Sponsor class: OTHER
First posted: 2022-12-23
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sentinel lymph node detection rate
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Manisa
country: Turkey
facility: Celal Bayar University
state: Yunusemre
Study officials:
affiliation: Celal Bayar University Department of General Surgery
name: Teoman Coskun, Prof.
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.