Study on Lymphedema Sensations After Breast Cancer Surgery
Who and Why do Patients Report Lymphedema After Breast Cancer Treatment Without an Objective Measurable Swelling
Recruiting
N/AInterventional Study
Breast CancerLymphedemaSensory Processing Disorder
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Screening
Participants needed
230 (estimated)
Sponsor
Universitaire Ziekenhuizen KU Leuven · Other
Who this trial is looking for
This trial is looking for adults who have been diagnosed with breast cancer. Participants will help researchers understand sensations of swelling in the arm and trunk over time after surgery.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years of age or older
I have been diagnosed with breast cancer
I am scheduled for breast surgery
I can read, understand, and speak Dutch
I have provided written consent to participate
You may not be able to join if
I have distant metastases
I am having bilateral lymph node surgery
I have arm swelling from another cause
I am allergic to iodine or Indocyanine Green
I am physically or mentally unable to participate throughout the study
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
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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, refe…
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).
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Eligibility 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)…
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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