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

Universitaire Ziekenhuizen KU Leuven

Status: Enrolling

Conditions: Sensory Processing Disorder; Breast Cancer; Lymphedema

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06324721

S68133

Details and patient eligibility

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).

Enrollment: 230 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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230 participants in 1 patient group

Breast cancer patients

Experimental group

Description:

Women and men who are being diagnosed with primary unilateral non-metastatic or oligometastatic breast cancer and scheduled for breast surgery in combination with axillary lymph node dissection or sentinel node biopsy

Treatment:

Other: Measurements for sensory processing problems by monofilaments, algometer, goniometer, and neurosensory analyzer

Other: Measurements for lymphatic problems (volumetric measurements, tissue dielectric measurement, lymphofluoroscopy)

Other: Measurements for breast cancer related lymphedema (volumetric measurements, bioimpedance spectroscopy, bioimpedance analysis, tissue dielectric constant measurements, ultrasonography)