Actively Recruiting
Who and Why do Patients Report Lymphedema After Breast Cancer Treatment Without an Objective Measurable Swelling
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2025-01-29
230
Participants Needed
1
Research Sites
161 weeks
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
U
Universiteit Antwerpen
Collaborating Sponsor
AI-Summary
What this Trial Is About
Breast cancer related lymphedema (BCRL) at the arm and/or trunk is an extremely dreaded complication after breast cancer treatment due to its chronicity and impact. The incidence of objective arm and trunk/ breast BCRL is declining due to the major shift into the treatment approach of breast cancer. However, many patients report a sensation of swelling without the presence of objective BCRL, referred to as subjective BCRL. Therefore, subjective BCRL is defined as the diagnosis of BCRL based on the patient's sensation of a difference in size at the arm and/or trunk without the presence of objective BCRL. At this moment, there is no clear information on the prevalence and the transitions between different BCRL states (no-subjective-objective) over time, as well as about the underlying mechanisms and contributing factors of subjective BCRL. Therefore, the investigators hypothesize that four mechanisms might be associated with the presence and severity of subjective arm or trunk/breast BCRL, including the presence and/ or severity of lymphatic (1) and sensory processing problems (nociceptive (2), neuropathic (3), and/or central sensory processing problems (4)). The investigators will set up a prospective longitudinal study with breast cancer patients to determine the prevalence of subjective and objective arm or trunk/ breast BCRL at 1, 6, and 12 month(s) post-surgery and the transitions between different BCRL states (no-subjective-objective BCRL) (AIM 1). In addition, factors related to four potential underlying mechanisms (lymphatic, nociceptive, neuropathic, and central sensory processing problems) that contribute to the occurrence of subjective BCRL in comparison to no self-reported swelling and objective BCRL will be determined (AIM 2). Furthermore, the present study will be undertaken to determine factors related to these four underlying mechanisms that contribute to the severity of subjective BCRL at arm or trunk/ breast BCRL within the group of patients with subjective BCRL at different time-points after surgery (at 1, 6, and 12 month(s) post-surgery) (AIM 3).
CONDITIONS
Official Title
Who and Why do Patients Report Lymphedema After Breast Cancer Treatment Without an Objective Measurable Swelling
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults (men and women) aged 18 years or older
- Diagnosed with primary unilateral non-metastatic or oligometastatic breast cancer
- Scheduled for surgery (mastectomy or breast conserving surgery) with axillary lymph node dissection or sentinel node biopsy
- Able to read, understand, and speak Dutch
- Provide voluntary written informed consent
You will not qualify if you...
- Presence of distant metastases
- Planned bilateral lymph node surgery
- Edema of the arm caused by another condition
- Allergy to iodine or Indocyanine Green (ICG)
- Physically or mentally unable to participate throughout the entire study duration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospitals of Leuven, center for lymphedema
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
Research Team
N
Nele Devoogdt, Prof. Dr.
CONTACT
C
Ceren Gursen, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here