Understanding why some breast cancer patients feel swelling without measurable lymphedema
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 230 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT06324721 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with unilateral non-metastatic or oligometastatic breast cancer who are scheduled for surgery.
Not a fit: Patients with distant metastases, planned bilateral lymph node surgery, or edema from other causes may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Leuven, Vlaams-Brabant
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.