Clinical trial · Observational
Axillary Web Syndrome After Breast Cancer Surgery: Incidence, Risk Factors, and Functional Outcomes
A Prospective Multicenter Cohort Study on the Incidence, Risk Factors, and Postoperative Functional Outcomes of Axillary Web Syndrome After Breast Cancer Surgery
- 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)
Axillary web syndrome (AWS), sometimes called "cording," is a condition that can develop after breast cancer surgery in which the lymph nodes under the arm are removed or sampled. It appears as one or more tight, painful cord-like structures running from the armpit down the inner arm. It can limit shoulder movement, cause pain, and interfere with daily activities. It is not yet clear how often AWS occurs, when it typically appears after surgery, which patients are most likely to develop it, or whether it is related to the arm swelling (lymphedema) that some patients experience after breast cancer treatment. Most previous studies looked back at patient records rather than following patients forward in time, so the answers remain uncertain. In this study, women who are having breast cancer surgery with either sentinel lymph node biopsy or axillary lymph node dissection will be examined before their operation and then at set times afterward: 2, 4, and 8 weeks, and 3 and 6 months. At each visit, the study doctor will examine the armpit and arm for cords, measure how far the shoulder can move, ask the patient to rate any pain, and measure the circumference of both arms to check for swelling. The study does not change the surgery or treatment a patient receives. It adds only these examinations and measurements, which are not painful and do not require blood tests or imaging. The researchers hope the results will help identify which patients are at higher risk, so that rehabilitation can be started earlier.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Axillary Web Syndrome | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer Lymphedema | — | UNRESOLVED | — |
| Postoperative Complications | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Axillary surgery (sentinel lymph node biopsy or axillary lymph node dissection) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients undergoing axillary surgery for breast cancer
- description
- Consecutive patients aged 18 years and older undergoing surgery for breast cancer with axillary staging by sentinel lymph node biopsy or axillary lymph node dissection at either participating center. All participants are assessed preoperatively and at weeks 2, 4, and 8 and months 3 and 6 postoperatively for the presence of axillary web syndrome, shoulder range of motion, pain intensity, and arm circumference. No study-specific alteration is made to surgical or oncological management.
- interventionNames
- Procedure: Axillary surgery (sentinel lymph node biopsy or axillary lymph node dissection)
Primary outcomes (2)
- measure
- Incidence of axillary web syndrome
- timeFrame
- From surgery through 6 months postoperatively
- description
- Proportion of participants in whom axillary web syndrome is identified at any postoperative assessment. Diagnosis is made clinically by inspection and palpation of a visible or palpable cord extending from the axilla along the upper extremity
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or older * Diagnosis of breast cancer with planned surgical treatment * Axillary staging performed by sentinel lymph node biopsy or axillary lymph node dissection * Written informed consent provided Exclusion Criteria: * Preoperative restriction of shoulder range of motion * History of neuromuscular disease affecting the upper extremity * Metastatic disease * Anticipated inability to comply with the follow-up protocol
References
Publications (3)
- BACKGROUNDBrunelle CL, Serig A. Is axillary web syndrome a risk factor for breast cancer-related lymphedema of the upper extremity? A systematic review and meta-analysis. Breast Cancer Res Treat. 2024 Dec;208(3):471-490. doi: 10.1007/s10549-024-07518-0. Epub 2024 Oct 16. PMID 39414730
- BACKGROUNDDinas K, Kalder M, Zepiridis L, Mavromatidis G, Pratilas G. Axillary web syndrome: Incidence, pathogenesis, and management. Curr Probl Cancer. 2019 Dec;43(6):100470. doi: 10.1016/j.currproblcancer.2019.02.002. Epub 2019 Mar 15. PMID 30898366
- BACKGROUNDGonzalez-Rubino JB, Vinolo-Gil MJ, Martin-Valero R. Effectiveness of physical therapy in axillary web syndrome after breast cancer: a systematic review and meta-analysis. Support Care Cancer. 2023 Apr 12;31(5):257. doi: 10.1007/s00520-023-07666-x. PMID 37043039