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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Incidence of axillary web syndrome — 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 — 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

Trial sites (2)

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