Early Diagnosis of Breast Cancer-related Lymphedema
ConditionLymphedema
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20-80
SponsorKaohsiung Veterans General Hospital.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial population
This study aims to recruit 100 breast cancer patients (those who have previously undergone or are expected to undergo any form of breast resection surgery) for research purposes.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
lymphoscintigraphy
Diagnostic testlymphoscintigraphy
circumference measurement
Diagnostic testcircumference measurement
sonography
Diagnostic testB-mode sono and elastography
DXA body composition analysis
Diagnostic testDXA body composition analysis
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: mastectomy4 interventions
Trial outcomes
Primary outcomes
1
circumference
Circumference measurements are taken and recorded at 2 cm intervals from the wrist crease to the armpit on both upper limbs
Time frame
everyday, through study completion, an average of 1 year2
Tissue compliance
Measurements are taken every 5 cm from the wrist crease to the armpit on both upper limbs using ShearWave Elastography
Time frame
every 1 week, through study completion, an average of 1 year3
Lymphoscintigraphy
Golden Standard for diagnosing lymphedema, used for detecting the location of lymphatic circulation blockage
Time frame
Once at the beginning of the study, and another assessment will be conducted six months later if there is a deterioration in lymphedema4
Indocyanine green (ICG) lymphography
Routine examination, used for detecting the type of lymphatic blockage
Time frame
Once at the beginning of the study, and another assessment will be conducted 3 months later if there is a deterioration in lymphedemaSponsors and contacts
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Source ClinicalTrials.gov