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

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

NCT ID: NCT06324721

Condition: Breast Cancer
Lymphedema
Sensory Processing Disorder

Conditions: Official terms:
Breast Neoplasms
Lymphedema

Conditions: Keywords:
lymphedema
subclinical edema
nociceptive problems
neuropathic problems
central sensory problems

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Prospective cohort study

Primary purpose: Screening

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Oedema measurements and sensory evaluations
Description: assessments of different types of arm and trunk/ breast oedema (self-reported swelling at arm and trunk/ breast, subjective arm lymphedema, subjective trunk/ breast lymphedema, objective arm lymphedema, objective trunk/ breast lymphedema)) clinical assessments for subclinical lymphedema and nociceptive, neuropathic and central sensory problems
Arm group label: Breast cancer patients

Summary: 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).

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University Hospitals of Leuven, center for lymphedema

Address:
City: Leuven
Zip: 3000
Country: Belgium

Status: Recruiting

Contact:
Last name: Nele Devoogdt
Email: nele.devoogdt@uzleuven.be

Contact backup:
Last name: Ceren Gursen
Email: ceren.guersen@kuleuven.be

Start date: March 26, 2024

Completion date: March 2027

Lead sponsor:
Agency: Universitaire Ziekenhuizen KU Leuven
Agency class: Other

Collaborator:
Agency: Universiteit Antwerpen
Agency class: Other

Source: Universitaire Ziekenhuizen KU Leuven

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06324721