Who and Why do Patients Report Lymphedema After Breast Cancer Treatment Without an Objective Measurable Swelling
Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Mar 19, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a condition called breast cancer-related lymphedema (BCRL), which can cause feelings of swelling in the arms or chest area after breast cancer treatment, even when there is no visible swelling. The researchers want to understand how many breast cancer patients experience this sensation, why it happens, and what factors may contribute to its severity. They suspect that issues with sensory processing, or problems with the lymphatic system (which helps transport fluids in the body), may play a role in these feelings of swelling.
To participate in the study, patients should be diagnosed with breast cancer and scheduled for surgery, such as a mastectomy or breast-conserving surgery, along with lymph node removal. Participants will be asked to attend follow-up appointments at 1, 6, and 12 months after surgery, during which they will be assessed for any sensations of swelling and other related factors. The study aims to improve our understanding of subjective lymphedema and help develop better support and treatment for those affected.
Gender
ALL
Eligibility criteria
- Inclusion criteria:
- • 1. adults (men and women) who are ≥ 18 years of age
- • 2. diagnosed with primary unilateral non-metastatic or oligometastatic breast cancer
- • 3. scheduled for surgery (mastectomy or breast conserving surgery; in combination with axillary lymph node dissection or sentinel node biopsy)
- • 4. able to read, understand, and speak Dutch
- • 5. have voluntary written informed consent of the patient
- Exclusion Criteria:
- • 1. distant metastases
- • 2. planned bilateral lymph node surgery
- • 3. oedema of the arm from another cause
- • 4. an allergy to iodine or Indocyanine Green (ICG), or
- • 5. physically or mentally unable to participate throughout the entire duration of the study
About Universitaire Ziekenhuizen Ku Leuven
Universitaire Ziekenhuizen KU Leuven is a leading academic medical center in Belgium, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. Affiliated with KU Leuven, one of Europe’s premier universities, the institution integrates cutting-edge scientific inquiry with high-quality patient care. It plays a pivotal role in the development and implementation of clinical trials, fostering collaboration between researchers, healthcare professionals, and industry partners to translate scientific discoveries into effective treatments. The hospital's multidisciplinary approach ensures comprehensive patient safety and ethical standards, positioning it as a trusted sponsor in the realm of clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Leuven, Vlaams Brabant, Belgium
Patients applied
Trial Officials
Nele Devoogdt, Prof. Dr.
Principal Investigator
KU Leuven
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported