Axillary Web Syndrome After Breast Cancer Surgery: Incidence, Risk Factors, and Functional Outcomes | NCT07780240 | Trialant

RecruitingObservationalUpdated Aug 21, 2026

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

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07780240
Lead Sponsor: Antalya City HospitalOTHER
Overall Status: Recruiting
Study Type: Observational
Enrollment: 250Estimated
Last Update Posted: Aug 21, 2026Actual
Start Date: May 1, 2026Actual
Primary Completion Date: Oct 2027Estimated
Completion Date: Oct 2027Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: A Prospective Multicenter Cohort Study on the Incidence, Risk Factors, and Postoperative Functional Outcomes of Axillary Web Syndrome After Breast Cancer Surgery
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.

Conditions

The medical conditions and diseases this study investigates.

Axillary Web Syndrome
Breast Cancer
Breast Cancer Lymphedema

Interventions

The treatments and procedures being evaluated in this study.

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

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Eligibility Criteria: 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

How the study is designed and how its participant groups are organized.

Observational Model: Cohort
Time Perspective: Prospective

Contacts

The people to reach with questions about this study or how to join it.

MEHMET OLCUM, MDContact

mehmetolcum@hotmail.com+905388101828

Locations

Where the study is run and whether each site is currently recruiting.

Bagcilar Training and Research HospitalRecruiting

Istanbul, BAGCILAR 34100, Turkey (Türkiye)

Collaborators

The organizations and people involved in this study.

Lead Sponsor: Antalya City HospitalOTHER
Collaborators

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Other registered studies that closely resemble this one.

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.