Axillary Web Syndrome After Breast Cancer Surgery: Incidence, Risk Factors, and Functional Outcomes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-80
SponsorAntalya City Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Axillary surgery (sentinel lymph node biopsy or axillary lymph node dissection)
Procedure/SurgeryAxillary 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.
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: Patients undergoing axillary surgery for breast cancer1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
From surgery through 6 months postoperatively2
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
Time frame
From surgery through 6 months postoperativelySecondary outcomes
1
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
Time frame
From surgery through 6 months postoperatively2
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
Time frame
Preoperatively and at weeks 2, 4, and 8 and months 3 and 6 postoperatively3
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
Time frame
Preoperatively and at weeks 2, 4, and 8 and months 3 and 6 postoperatively4
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
Time frame
From surgery through 6 months postoperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Antalya City Hospital
Lead sponsor
İstanbul Bağcılar Training and Research Hospital
Collaborator
Source ClinicalTrials.gov