Clinical trial · Interventional
Does Immediate Lymphatic Reconstruction Decrease the Risk of Lymphedema After Axillary Lymph Node Dissection
A Randomized Controlled Trial: Does Immediate Lymphatic Reconstruction Decrease the Incidence of Lymphedema After Axillary Lymph Node Dissection
- 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)
The researchers are doing this study to see if having immediate lymphatic reconstruction after axillary lymph node dissection (ALND) can decrease the development of lymphedema, a side effect of ALND. Other purposes of the study include: Comparing the approach of immediate lymphatic reconstruction after ALND with the approach of ALND alone Looking at whether having immediate lymphatic reconstruction after ALND improves a person's quality of life Seeing if adding standard of care radiation therapy to either study approach (immediate lymphatic reconstruction after ALND or ALND alone) has an effect on development of 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 Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction | Procedure | — | UNRESOLVED |
| Axillary Lymph Node Dissection without Immediate Lymphatic Reconstruction | Procedure | — | UNRESOLVED |
| measured by arm volume | Other | — | UNRESOLVED |
| quality-of-life questionnaires | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- axillary lymph node dissection with ILR
- interventionNames
- Procedure: Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction
- Other: quality-of-life questionnaires
- Other: measured by arm volume
- type
- ACTIVE_COMPARATOR
- label
- axillary lymph node dissection (ALND) without ILR
- interventionNames
- Procedure: Axillary Lymph Node Dissection without Immediate Lymphatic Reconstruction
- Other: quality-of-life questionnaires
- Other: measured by arm volume
Primary outcomes (1)
- measure
- the number of patients that had a decrease incidence of lymphedema
- timeFrame
- up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Female breast cancer patients 18-75 years of age * Patients consenting for unilateral ALND (prior history of SLNBx allowed if \<6 months from consent) OR patients consenting for unilateral SLNBx with possible ALND, with a clinically or radiographically positive lymph node OR a high likelihood of ALND per the Breast Surgeon * Identification of at least one transected lymphatic channel and at least one vein to be used for bypass at the time of ALND during surgery Exclusion Criteria: * Male breast cancer patients * Non-English speaking participants * Female breast cancer patients with axillary recurrence * Female breast cancer patients who have a history of ALND * Female patients requiring bilateral ALND for the treatment of their breast cancer * Female breast patients treated with SLNBx only
References
Publications (0)
Data not yet available