Clinical trial NCT06324721: Who and Why do Patients Report Lymphedema After Breast Cancer Treatment Without an Objective Measurable Swelling
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lymphedema
Sensory Processing Disorder
Keywords: lymphedema
subclinical edema
nociceptive problems
neuropathic problems
central sensory problems
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Universiteit Antwerpen
First posted: 2024-03-22
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective cohort study
Primary purpose: SCREENING

Brief summary: 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).


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)
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

Primary outcomes:
measure: Presence of subjective arm lymphedema
timeFrame: Time frame up to 12 months post-surgery
measure: Presence of subjective trunk/ breast lymphedema
timeFrame: Time frame up to 12 months post-surgery
measure: Presence of objective arm lymphedema
timeFrame: Time frame up to 12 months post-surgery
measure: Presence of objective trunk/ breast lymphedema
timeFrame: Time frame up to 12 months post-surgery
Secondary outcomes:
measure: Amount of swelling at upper limb and trunk/breast
timeFrame: Time frame up to 12 months post-surgery
measure: Severity of dermal rerouting at upper limb and trunk/breast
timeFrame: Time frame up to 12 months post-surgery
measure: Severity of myofascial adhesions at the level of the scars
timeFrame: Time frame up to 12 months post-surgery
measure: Severity of local muscle stiffness
timeFrame: Time frame up to 12 months post-surgery
measure: Severity of local muscle tenderness
timeFrame: Time frame up to 12 months post-surgery
measure: Severity of impaired shoulder range of motion
timeFrame: Time frame up to 12 months post-surgery
measure: Presence of neuropathic pain at upper arm and trunk
timeFrame: Time frame up to 12 months post-surgery
measure: Severity of sensory loss at the arm and trunk
timeFrame: Time frame up to 12 months post-surgery
measure: Severity of altered cold sensation sensitivity at the arm and trunk
timeFrame: Time frame up to 12 months post-surgery
measure: Severity of altered heat sensation sensitivity at the arm and trunk
timeFrame: Time frame up to 12 months post-surgery
measure: Severity of altered sensory acuity in the arm and trunk
timeFrame: Time frame up to 12 months post-surgery
measure: Severity of widespread hyperalgesia
timeFrame: Time frame up to 12 months post-surgery
measure: Efficacy of inhibitory pain mechanism
timeFrame: Time frame up to 12 months post-surgery
measure: Degree of pain facilitation
timeFrame: Time frame up to 12 months post-surgery
measure: Severity of altered body perception
timeFrame: Time frame up to 12 months post-surgery
measure: Severity of subjective arm lymphedema
timeFrame: Time frame up to 12 months post-surgery
measure: Severity of subjective trunk lymphedema
timeFrame: Time frame up to 12 months post-surgery
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals of Leuven, center for lymphedema
state: Vlaams-Brabant
Study officials:
affiliation: KU Leuven
name: Nele Devoogdt, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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