protocolSection identificationModule nctId: NCT06324721, orgStudyIdInfo id: S68133, briefTitle: Why do Patients Report Lymphedema After Breast Cancer Treatment Without an Objective Measurable Swelling, acronym: LymphSens, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, collaborators name: Universiteit Antwerpen, descriptionModule briefSummary: 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)., conditionsModule conditions: Breast Cancer, conditions: Lymphedema, conditions: Sensory Processing Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective cohort study, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 230, type: ESTIMATED, armsInterventionsModule interventions name: Oedema measurements and sensory evaluations, outcomesModule primaryOutcomes measure: Presence of self-reported swelling at arm, primaryOutcomes measure: Presence of self-reported swelling at trunk, primaryOutcomes measure: Presence of self-reported swelling at breast, primaryOutcomes measure: Presence of subjective arm lymphedema, primaryOutcomes measure: Presence of subjective trunk lymphedema, primaryOutcomes measure: Presence of subjective breast lymphedema, primaryOutcomes measure: Relative hand volume difference, primaryOutcomes measure: Relative arm volume difference, primaryOutcomes measure: Extra-cellular water ratio by Bioimpedance Analysis, primaryOutcomes measure: Extra-cellular water ratio by Bioimpedance Spectroscopy, primaryOutcomes measure: Presence of objective arm lymphedema, primaryOutcomes measure: Relative percentage of water content (PWC) ratio, primaryOutcomes measure: Skin thickness, primaryOutcomes measure: Presence of objective trunk lymphedema, primaryOutcomes measure: Presence of objective breast lymphedema, secondaryOutcomes measure: Dermal rerouting score at arm, secondaryOutcomes measure: Dermal rerouting score at trunk, secondaryOutcomes measure: Severity of myofascial adhesions, secondaryOutcomes measure: Myofascial tissue stiffness, secondaryOutcomes measure: Pressure pain thresholds, secondaryOutcomes measure: Arm abduction range, secondaryOutcomes measure: Presence of neuropathic pain, secondaryOutcomes measure: Mechanical detection thresholds, secondaryOutcomes measure: Thermal detection and pain thresholds, secondaryOutcomes measure: Sensory acuity, secondaryOutcomes measure: Dysfunctional inhibitory pain mechanism, secondaryOutcomes measure: Enhanced facilitating mechanism, secondaryOutcomes measure: Body perception, secondaryOutcomes measure: Severity of subjective arm lymphedema, secondaryOutcomes measure: Severity of subjective trunk lymphedema, secondaryOutcomes measure: Severity of subjective breast lymphedema, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospitals of Leuven, center for lymphedema, status: RECRUITING, city: Leuven, state: Vlaams-Brabant, zip: 3000, country: Belgium, contacts name: Nele Devoogdt, role: CONTACT, email: nele.devoogdt@uzleuven.be, contacts name: Ceren Gursen, role: CONTACT, email: ceren.guersen@kuleuven.be, geoPoint lat: 50.87959, lon: 4.70093, hasResults: False