Clinical trial · Interventional
Is Breast Massage Necessary to Find Sentinel Lymph Node?
Is Breast Massage Necessary to Find Sentinel Lymph Node After Isosulfan Blue Injection in Patients With Breast Cancer? A Prospective Randomized Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Sentinel Lymph Node | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blue dye injection | Procedure | — | UNRESOLVED |
| Breast massage | Procedure | — | UNRESOLVED |
| Sentinel lymph node biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm with massage
- description
- 5 ml of isosulfan blue will be injected into the subareolar region. 5-minutes massage will be applied. Drug: Isosulfan Blue 5 ml
- interventionNames
- Procedure: Sentinel lymph node biopsy
- Procedure: Breast massage
- Procedure: Blue dye injection
- type
- EXPERIMENTAL
- label
- Arm without massage
- description
- 5 ml of isosulfan blue will be injected into the subareolar region. No massage will be applied. Drug: Isosulfan Blue 5 ml
- interventionNames
- Procedure: Sentinel lymph node biopsy
- Procedure: Blue dye injection
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- RESULTShenoy 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. PMID 14965682
- RESULTBass 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. PMID 11192930
- RESULTDiaz 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. PMID 15614159