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

19 augusti 2026 uppdaterad av: Mehmet Ölçüm, Antalya City Hospital

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

250

Kontakter och platser

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Studiekontakt

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Studieorter

  • Turkiet (Türkiye)
    • BAGCILAR
      • Istanbul, BAGCILAR, Turkiet (Türkiye), 34100
        • Rekrytering
        • Bagcilar Training and Research Hospital
        • Kontakt:
    • Kepez
      • Antalya, Kepez, Turkiet (Türkiye), 07080
        • Rekrytering
        • Antalya City Hospital
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Consecutive patients undergoing surgery for breast cancer with axillary staging by sentinel lymph node biopsy or axillary lymph node dissection at the general surgery departments of the two participating centers. Patients who develop axillary web syndrome and those who do not are compared within the same cohort; no separate control group is enrolled.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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.
Procedur: Axillary 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Incidence of axillary web syndrome
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Risk factors associated with development of axillary web syndrome
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Antalya City Hospital

Samarbetspartners

İstanbul Bağcılar Training and Research Hospital

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 maj 2026

Primärt slutförande (Beräknad)

1 oktober 2027

Avslutad studie (Beräknad)

1 oktober 2027

Studieregistreringsdatum

Först inskickad

19 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

19 augusti 2026

Första postat (Faktisk)

21 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

21 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

19 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 215/2026

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

Individual participant data will not be shared. The study protocol and informed consent do not include provisions for sharing individual-level data with parties outside the research team.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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