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

Recruiting
18 years of age
Both
Phase N/A

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Overview

Breast cancer related lymphedema (BCRL) is due to its chronicity and impact an extremely dreaded complication after breast cancer treatment.

The prevalence rate of objective arm and trunk/ breast BCRL is declining due to the major shift into the treatment approach of breast cancer. However, the prevalence rate of subjective arm and trunk/ breast BCRL is much higher than that of objective BCRL. 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 any objectively measurable swelling.

At this moment, it is not clear how many breast cancer patients experience subjective arm or trunk/breast BCRL and what the underlying mechanisms may be. Therefore, the investigators hypothesize that four mechanisms might be associated with the presence and the severity of subjective arm or trunk/breast BCRL, including sensory processing problems (1. nociceptive and/or 2. neuropathic and/or 3. central) and the presence of disturbed lymphatic transport without clinical manifestation (4. subclinical BCRL).

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 the different types of BCRL and to compare the amount of swelling at arm or trunk/ breast, the presence or severity of subclinical BCRL and peripheral and central sensory processing problems between patients with different types of BCRL. In addition, the present study will be undertaken to determine the contributing factors to the severity of subjective 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).

Eligibility

Inclusion Criteria:

  1. Diagnosis of primary unilateral breast cancer or oligo-metastatic breast cancer
  2. Patients scheduled for surgery (mastectomy or breast conserving surgery; in combination with axillary lymph node dissection or sentinel node biopsy)
  3. Able to read, understand, and speak Dutch
  4. Having voluntary written informed consent of the participant prior to any screening procedures.

Exclusion Criteria:

  1. Patients with widespread distance metastasis, previous breast surgery, or planned bilateral surgery
  2. Oedema of the arm from other cause
  3. Allergy for iodine, sodium iodine, or Indocyanine Green
  4. Physically or mentally unable to participate during the entire duration of the study.

Study details

Breast Cancer, Lymphedema, Sensory Processing Disorder

NCT06324721

Universitaire Ziekenhuizen KU Leuven

1 May 2024

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