Clinical trial · Observational
Early Diagnosis of Breast Cancer-related Lymphedema
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will conduct clinical trials to explore the mechanisms behind the development of upper limb lymphedema following breast cancer surgery. The investigators will recruit patients who have undergone breast cancer surgery and utilize Indocyanine Green (ICG) lymphography and Lymphoscintigraphy to identify the locations of lymphatic blockages. Shear Wave Elastography (SWE) will be used to detect changes in tissue limb compliance. DXA body composition analysis will measure the differences in the composition ratios between edematous and normal limbs. In addition, diffusion correlation spectrometry will be employed to monitor changes in deep tissue blood flow, complemented by continuous measurements of limb circumference and other physiological parameters. The study aims to explore the interrelationships among lymphatic circulation, limb circumference, tissue compliance, and tissue blood flow rates.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| circumference measurement | Diagnostic Test | — | UNRESOLVED |
| DXA body composition analysis | Diagnostic Test | — | UNRESOLVED |
| lymphoscintigraphy | Diagnostic Test | — | UNRESOLVED |
| sonography | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- mastectomy
- description
- Expected to include female patients who are undergoing breast cancer resection surgery or those who have already undergone breast resection surgery for breast cancer.
- interventionNames
- Diagnostic Test: lymphoscintigraphy
- Diagnostic Test: circumference measurement
- Diagnostic Test: sonography
- Diagnostic Test: DXA body composition analysis
Primary outcomes (5)
- measure
- circumference
- timeFrame
- everyday, through study completion, an average of 1 year
- description
- Circumference measurements are taken and recorded at 2 cm intervals from the wrist crease to the armpit on both upper limbs
- measure
- Tissue compliance
- timeFrame
- every 1 week, through study completion, an average of 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients who are expected to undergo breast cancer resection surgery or have already undergone breast resection surgery for breast cancer. * Absence of unhealed open wounds or other conditions unsuitable for tactile measurements within the measurement area. * No severe cognitive or emotional impairments. * No substance abuse (alcohol or drugs). * Females aged between 20 and 80, capable of fully complying with the requirements of this study plan. Exclusion Criteria: * Presence of unhealed open wounds or other conditions unsuitable for tactile measurements within the measurement area. * Upper limb abnormalities in function (including joint mobility and muscle strength). * Significant cognitive, auditory, or expressive language issues that hinder comprehension and compliance with instructions. * Lack of assistance for daily measurements.
References
Publications (0)
Data not yet available