Understanding why some breast cancer patients feel swelling without measurable lymphedema
Official title: The Enigma of Subjective Lymphedema: Who and Why do Patients Report Lymphedema After Breast Cancer Treatment Without an Objective Measurable Swelling? The Role of Lymphatic and Sensory Processing Problems
Run by Universitaire Ziekenhuizen KU Leuven · NCT06324721 · Data updated 2026-11-12
This study is trying to understand why some breast cancer patients feel swelling in their arms or chest even when tests show they don't have lymphedema, to help improve their care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 230 (estimated) |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Status | Recruiting |
| Started | March 26, 2024 |
| Main results expected | May 2027 |
| Study ends | May 2027 |
| Registry record updated | January 29, 2025 |
| Trial ID | NCT06324721 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older diagnosed with unilateral non-metastatic or oligometastatic breast cancer who are scheduled for surgery.
✕Probably not a fit
Patients with distant metastases, planned bilateral lymph node surgery, or edema from other causes may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the phenomenon of subjective breast cancer-related lymphedema (BCRL), where patients report sensations of swelling despite no objective evidence of lymphedema. It aims to explore the prevalence and transitions between different states of BCRL over time, as well as the underlying mechanisms contributing to these sensations. Various measurement techniques will be employed, including volumetric measurements, bioimpedance spectroscopy, and sensory processing assessments. The goal is to better understand the factors influencing subjective BCRL to improve patient care.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients experiencing subjective sensations of swelling after breast cancer treatment.
How similar studies have gone: While the specific focus on subjective BCRL is novel, related studies on lymphedema have shown varying degrees of success in understanding and managing the condition.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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University Hospitals of Leuven, center for lymphedema
Leuven, Vlaams-Brabant, Belgium Recruiting
Study contacts
- Principal investigator: Nele Devoogdt, Prof. Dr. — KU Leuven
- Study coordinator: Nele Devoogdt, Prof. Dr.
- Email: nele.devoogdt@uzleuven.be
- Phone: 003216342515
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Comparing two nerve-block options to reduce pain after total mastectomy.
This test tries whether a PECS-II block given before surgery or a pectoral block given during surgery, using bupivacaine or liposomal bupivacaine, provides better pain control after total mastectomy for breast cancer or high-risk patients.
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Developing a treatment protocol for chronic lymphedema after breast cancer surgery
This study is trying to create a clear treatment plan for managing chronic lymphedema after breast cancer surgery to help improve patients' lives and make it easier for them to get insurance coverage for the care they need.
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Program to prevent lymphedema after breast cancer surgery
This study is testing a prevention program to help women who have breast cancer surgery avoid lymphedema by using treatments like lymphatic massage and special garments.
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Upfront treatment for breast cancer with nodal metastases
This study is testing if starting treatment with surgery and targeted therapy can help women with early-stage breast cancer that has spread to their lymph nodes live longer and have fewer recurrences.
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Screening for Breast Cancer-Related Lymphedema in Targeted Therapy
This study tests whether targeted breast cancer therapies are linked to lymphedema by tracking arm volume and symptoms in women undergoing treatment.
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Preventing lymphedema after breast cancer surgery
This study is testing a new procedure to see if connecting lymph vessels can help prevent swelling in the arm for women having surgery for breast cancer.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.