Axillary Web SyndromeNCT07780240
Axillary Web Syndrome After Breast Cancer Surgery: Incidence, Risk Factors, and Functional Outcomes
An observational study of Axillary Web Syndrome and Breast Cancer, run by Antalya City Hospital at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Axillary Web Syndrome, Breast Cancer, Breast Cancer Lymphedema
- What is being tested?
- Axillary surgery (sentinel lymph node biopsy or axillary lymph node dissection)
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 May 2026to Oct 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Antalya City Hospital
Antalya, Kepez, 07080
Mehmet Olcum, MD, +905388101828, mehmetolcum@hotmail.com
- Recruiting
Bagcilar Training and Research Hospital
Istanbul, BAGCILAR, 34100
Merve Tokocin, MD, +905356235594, mervetokocin@gmail.com
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Axillary Web Syndrome, Breast Cancer, Breast Cancer Lymphedema, Postoperative Complications
- Being tested
- Axillary surgery (sentinel lymph node biopsy or axillary lymph node dissection)
- 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
- Medical subject headings
- Breast Neoplasms, Breast Cancer Lymphedema, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axillary surgery (sentinel lymph node biopsy or axillary lymph node dissection)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Axillary surgery (sentinel lymph node biopsy or axillary lymph node dissection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of axillary web syndrome
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
Measured: From surgery through 6 months postoperatively
Time to onset of axillary web syndrome
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
Measured: From surgery through 6 months postoperatively
Secondary outcomes (5)
Risk factors associated with development of axillary web syndrome
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
Measured: From surgery through 6 months postoperatively
Shoulder range of motion
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
Measured: Preoperatively and at weeks 2, 4, and 8 and months 3 and 6 postoperatively
Pain intensity measured by Visual Analog Scale
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
Measured: 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
Development of lymphedema assessed by bilateral upper extremity circumference measurements, and its association with the presence of axillary web syndrome
Measured: From surgery through 6 months postoperatively
Time to resolution of axillary web syndrome with conservative management
Time from detection of axillary web syndrome to clinical resolution of the cord in participants receiving conservative management
Measured: From detection through 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start1 May 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Axillary Web SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Antalya City Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- İstanbul Bağcılar Training and Research Hospital
- Responsible party
- Principal investigator, Mehmet Ölçüm, Antalya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07780240
- Sponsor's protocol ID
- 215/2026
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 39414730Dinas 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.
PubMed 30898366Gonzalez-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.
PubMed 37043039
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Cohort Study on the Incidence, Risk Factors, and Postoperative Functional Outcomes of Axillary Web Syndrome After Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT07780240
- Acronym / sponsor ID
- 215/2026
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Antalya City HospitalUniversity, hospital or other
- Collaborators
- İstanbul Bağcılar Training and Research Hospital
- Study start
- 1 May 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing axillary surgery for breast cancer | – | Procedure: Axillary surgery (sentinel lymph node biopsy or axillary lymph node dissection)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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Patients undergoing axillary surgery for breast cancer |
Primary outcome
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
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
5 secondary outcomes
Risk factors associated with development of axillary web syndrome
Time frame: 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
Pain intensity measured by Visual Analog Scale
Time frame: 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
Time to resolution of axillary web syndrome with conservative management
Time frame: From detection through 6 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Background: PubMed 39414730Brunelle 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.
- Background: PubMed 30898366Dinas 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.
- Background: PubMed 37043039Gonzalez-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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Axillary Web Syndrome and Breast Cancer, run by Antalya City Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MEHMET OLCUM, MD (+905388101828, mehmetolcum@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of axillary web syndrome (time frame: From surgery through 6 months postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07780240, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.