Clinical trial · Interventional
A Study of a Comprehensive Prevention Program to Reduce Lymphedema After Axillary Lymph Node Dissection in People With Breast Cancer
A Prospective Cohort Study of Patients Undergoing ALND for Treatment of Breast Cancer: The Efficacy of a Comprehensive Prevention Program in Decreasing the Incidence of Lymphedema and Improving Quality of Life
NCT06144164CI-TRIAL-00097108recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of this study to test whether a comprehensive program may help the lymph fluid to drain out of the arm and prevent lymphedema in participants with breast cancer.
Conditions
Conditions (6)
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 |
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Female Breast Cancer | — | UNRESOLVED | — |
| Lymphedema | — | UNRESOLVED | — |
| Lymphedema Arm | — | UNRESOLVED | — |
| Lymphedema of Upper Arm | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Compression garment use | Other | — | UNRESOLVED |
| Immediate Lymphatic Reconstruction | Procedure | — | UNRESOLVED |
| Lymphatic massage | Other | — | UNRESOLVED |
| Range of motion exercises | Other | — | UNRESOLVED |
| Volumetric arm measurements | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Participants with Breast Cancer
- description
- Participants will have a diagnosis of breast cancer and may undergo axillary lymph node dissection.
- interventionNames
- Procedure: Immediate Lymphatic Reconstruction
- Diagnostic Test: Volumetric arm measurements
- Other: Lymphatic massage
- Other: Range of motion exercises
- Other: Compression garment use
Primary outcomes (1)
- measure
- The difference between the baseline and postoperative arm volume measurement
- timeFrame
- Up to 24 months
- description
- The primary objective is to determine the efficacy of a prevention program in decreasing the development of lymphedema in participants treated for breast cancer with Axillary Lymph Node Dissection/ALND by use of arm volume measurements. A ≥ 10% increase in RVC (arm volume difference between the affected and unaffected arms) between baseline and postoperative measures occurring at 12 months or later will indicate the development of lymphedema
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Female sex * Diagnosis of breast cancer * Ages 18 to 75 years * Consented for unilateral ALND or for unilateral SLNB with possible ALND Exclusion Criteria: * Male sex * Does not speak English * Does not fit into study garment * Axillary recurrence * History of ALND * Requirement of bilateral ALND for the treatment of breast cancer * Treatment with SLNB only * Known anaphylactic allergy to ICG dye used in ILR * Impaired decision-making capacity
References
Publications (0)
Data not yet available
No reference posted for this study.