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
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Background and Rationale
Axillary web syndrome is a postoperative complication characterized by palpable, often painful fibrotic cords extending from the axilla along the upper extremity, occurring after axillary lymph node dissection (ALND) or sentinel lymph node biopsy (SLNB) for breast cancer. It may lead to restricted shoulder range of motion, pain, functional loss, and reduced quality of life.
Reported incidence in the literature ranges from approximately 28% to 40%. However, the majority of published studies are retrospective in design, and prospective data obtained through regular, structured physical examination are limited. The risk factors for AWS and its relationship with breast cancer-related lymphedema (BCRL) remain insufficiently defined.
A prospective cohort study using systematic postoperative follow-up and standardized measurements is therefore expected to characterize the true incidence, timing, clinical course, and risk factors of AWS more reliably.
Design and Setting
This is a prospective, observational, multicenter cohort study conducted at two general surgery departments. The study population consists of consecutive patients undergoing surgery for breast cancer with axillary staging (SLNB or ALND) at either participating center. No separate control group is included; patients who develop AWS will be compared with those who do not within the same cohort.
To ensure data consistency across centers, all assessments are performed using a predefined standardized data collection form and identical measurement methods.
Assessments
Preoperative assessment: demographic data, body mass index, TNM stage, and comorbid conditions are recorded. Shoulder range of motion is measured with a goniometer and pain intensity is assessed using a Visual Analog Scale (VAS).
Operative data: type of surgery performed, number of lymph nodes removed, operative time, and early postoperative complications are recorded.
Postoperative follow-up: patients are assessed at fixed time points (weeks 2, 4, and 8; months 3 and 6). At each visit, the presence of AWS is investigated by inspection and palpation, with the number and anatomical location of cords recorded; shoulder range of motion is measured by goniometry; pain intensity is assessed by VAS; and development of BCRL is evaluated by bilateral arm circumference measurements.
Patients diagnosed with AWS receive conservative management according to routine institutional practice, and time to resolution is recorded.
Data Handling
Data from both centers are anonymized and pooled into a common database for analysis.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mehmet Olcum, MD
- Phone Number: +905388101828
- Email: mehmetolcum@hotmail.com
Study Contact Backup
- Name: Merve Tokocin, MD
- Phone Number: +905356235594
- Email: mervetokocin@gmail.com
Study Locations
-
-
BAGCILAR
-
Istanbul, BAGCILAR, Turkey (Türkiye), 34100
- Recruiting
- Bagcilar Training and Research Hospital
-
Contact:
- Merve Tokocin, MD
- Phone Number: +905356235594
- Email: mervetokocin@gmail.com
-
-
Kepez
-
Antalya, Kepez, Turkey (Türkiye), 07080
- Recruiting
- Antalya City Hospital
-
Contact:
- Mehmet Olcum, MD
- Phone Number: +905388101828
- Email: mehmetolcum@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients undergoing axillary surgery for breast cancer
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.
|
Axillary staging performed as part of routine breast cancer surgical management, either as sentinel lymph node biopsy or axillary lymph node dissection.
The choice of procedure is made according to standard clinical indications and is not determined by the study protocol.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of axillary web syndrome
Time Frame: From surgery through 6 months postoperatively
|
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
|
From surgery through 6 months postoperatively
|
|
Time to onset of axillary web syndrome
Time Frame: From surgery through 6 months postoperatively
|
The postoperative assessment visit at which axillary web syndrome is first detected, among participants who develop it.
Assessments occur at weeks 2, 4, and 8 and at months 3 and 6
|
From surgery through 6 months postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Risk factors associated with development of axillary web syndrome
Time Frame: From surgery through 6 months postoperatively
|
Association between development of axillary web syndrome and age, body mass index, type of axillary surgery (sentinel lymph node biopsy versus axillary lymph node dissection), number of lymph nodes removed, adjuvant therapy received, and comorbid conditions
|
From surgery through 6 months postoperatively
|
|
Shoulder range of motion
Time Frame: Preoperatively and at weeks 2, 4, and 8 and months 3 and 6 postoperatively
|
Shoulder range of motion of the operated side measured in degrees by goniometry, compared between participants who develop axillary web syndrome and those who do not
|
Preoperatively and at weeks 2, 4, and 8 and months 3 and 6 postoperatively
|
|
Pain intensity measured by Visual Analog Scale
Time Frame: Preoperatively and at weeks 2, 4, and 8 and months 3 and 6 postoperatively
|
Pain intensity in the operated upper extremity rated on a Visual Analog Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain
|
Preoperatively and at weeks 2, 4, and 8 and months 3 and 6 postoperatively
|
|
Incidence of breast cancer-related lymphedema and its association with axillary web syndrome
Time Frame: From surgery through 6 months postoperatively
|
Development of lymphedema assessed by bilateral upper extremity circumference measurements, and its association with the presence of axillary web syndrome
|
From surgery through 6 months postoperatively
|
|
Time to resolution of axillary web syndrome with conservative management
Time Frame: From detection through 6 months postoperatively
|
Time from detection of axillary web syndrome to clinical resolution of the cord in participants receiving conservative management
|
From detection through 6 months postoperatively
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Dinas 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.
- Gonzalez-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.
- Brunelle 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Site
- Neoplasms
- Skin Diseases
- Breast Diseases
- Lymphatic Diseases
- Lymphedema
- Pathological Conditions, Signs and Symptoms
- Skin and Connective Tissue Diseases
- Hemic and Lymphatic Diseases
- Breast Cancer Lymphedema
- Breast Neoplasms
- Postoperative Complications
- Investigative Techniques
- Specimen Handling
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Surgical Procedures, Operative
- Cytological Techniques
- Biopsy
- Cytodiagnosis
- Diagnostic Techniques, Surgical
- Lymph Node Excision
- Sentinel Lymph Node Biopsy
Other Study ID Numbers
- 215/2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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