Clinical trial · Interventional
Axillary Lymph Node Preservation Surgery in Reducing Lymphedema in Patients With Breast Cancer
Reducing Extremity Lymphedema Through Axillary Lymphatic Preservation Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Loss of principal investigator
Summary
Brief summary (as posted)
This pilot phase I and randomized phase II trial studies the best way to perform axillary lymph node preservation surgery and to see how well it works in preventing lymphedema in patients with breast cancer. Lymph node mapping may help in planning surgery to remove breast cancer and affected lymph nodes. It is not yet known whether reverse mapping guided axillary lymph node dissection is more effective than standard axillary lymph node dissection in preventing lymphedema.
Conditions
Conditions (1)
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 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| axillary lymph node dissection | Procedure | — | UNRESOLVED |
| isosulfan blue based lymphatic mapping | Drug | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| Questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (reverse mapping guided axillary lymph node dissection)
- description
- Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.
- interventionNames
- Procedure: axillary lymph node dissection
- Drug: isosulfan blue based lymphatic mapping
- Procedure: quality-of-life assessment
- Other: Questionnaire administration
- type
- ACTIVE_COMPARATOR
- label
- Arm II (control)
- description
- Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.
- interventionNames
- Drug: isosulfan blue based lymphatic mapping
- Procedure: axillary lymph node dissection
- Procedure: quality-of-life assessment
- Other: Questionnaire administration
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: \- Patients diagnosed with breast cancer with a planned axillary lymph node dissection planned for breast cancer Exclusion Criteria: * Prior lymphedema in either arm * Prior history of axillary surgery (except for sentinel node biopsies) * Prior history of chest/axillary radiation * Need for bilateral axillary node dissection surgery * Prior neurologic deficits (either motor or sensory) in ipsilateral arm * Known allergy to vital blue dyes * No prior diagnosis of inflammatory breast cancer * Cannot be pregnant or planning to continue breast-feeding immediately after surgery
References
Publications (0)
Data not yet available