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Who and Why do Patients Report Lymphedema After Breast Cancer Treatment Without an Objective Measurable Swelling

RecruitingNAAges 18 Years - anyAllUniversitaire Ziekenhuizen KU Leuven
NCT06324721 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 fo

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📋 Eligibility rules (as published)
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
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What it tests

  • Measurements for breast cancer related lymphedema (volumetric measurements, bioimpedance spectroscopy, bioimpedance analysis, tissue dielectric constant measurements, ultrasonography)
  • Measurements for lymphatic problems (volumetric measurements, tissue dielectric measurement, lymphofluoroscopy)
  • Measurements for sensory processing problems by monofilaments, algometer, goniometer, and neurosensory analyzer
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Where

1 site
University Hospitals of Leuven, center for lymphedema
Leuven, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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