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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Antalya City Hospital
RECRUITING
Antalya
Bagcilar Training and Research Hospital
RECRUITING
Istanbul
Contact Information
Primary
MEHMET OLCUM, MD
mehmetolcum@hotmail.com
+905388101828
Backup
MERVE TOKOCIN, MD
mervetokocin@gmail.com
+905356235594
Time Frame
Start Date: 2026-05-01
Estimated Completion Date: 2027-10
Participants
Target number of participants: 250
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Antalya City Hospital
Collaborators: İstanbul Bağcılar Training and Research Hospital

This content was sourced from clinicaltrials.gov