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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07780240
Enrollment
250
Registered
2026-08-21
Start date
2026-05-01
Completion date
2027-10-01
Last updated
2026-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Axillary Web Syndrome, Breast Cancer, Breast Cancer Lymphedema, Postoperative Complications

Keywords

axillary web syndrome, cording, lymphatic cording, sentinel lymph node biopsy, axillary lymph node dissection, shoulder range of motion, breast cancer surgery, postoperative morbidity, prospective cohort

Brief summary

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.

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.

Interventions

PROCEDUREAxillary surgery (sentinel lymph node biopsy or axillary lymph node dissection)

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.

Sponsors

Antalya City Hospital
Lead SponsorOTHER
İstanbul Bağcılar Training and Research Hospital
CollaboratorUNKNOWN

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of axillary web syndromeFrom surgery through 6 months postoperativelyProportion 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
Time to onset of axillary web syndromeFrom surgery through 6 months postoperativelyThe 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

Secondary

MeasureTime frameDescription
Shoulder range of motionPreoperatively and at weeks 2, 4, and 8 and months 3 and 6 postoperativelyShoulder 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
Pain intensity measured by Visual Analog ScalePreoperatively and at weeks 2, 4, and 8 and months 3 and 6 postoperativelyPain 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
Incidence of breast cancer-related lymphedema and its association with axillary web syndromeFrom surgery through 6 months postoperativelyDevelopment of lymphedema assessed by bilateral upper extremity circumference measurements, and its association with the presence of axillary web syndrome
Risk factors associated with development of axillary web syndromeFrom surgery through 6 months postoperativelyAssociation 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
Time to resolution of axillary web syndrome with conservative managementFrom detection through 6 months postoperativelyTime from detection of axillary web syndrome to clinical resolution of the cord in participants receiving conservative management

Countries

Turkey (Türkiye)

Contacts

CONTACTMEHMET OLCUM, MD
mehmetolcum@hotmail.com+905388101828
CONTACTMERVE TOKOCIN, MD
mervetokocin@gmail.com+905356235594

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 22, 2026