Kaohsiung Veterans General Hospital
Kaohsiung City, 81362, Taiwan
Location status: Recruiting
NCT Number: NCT06046365
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.
Interested in participating?
Request Info20 year–80 year
Female
Observational
Kaohsiung City, 81362, Taiwan
Location status: Recruiting
Breast cancer ranks as the most common cancer among women in Taiwan. According to the cancer registry data of Taiwan's Ministry of Health and Welfare, there were 16,325 new cases of breast cancer in 2016. Approximately one in 12 women will develop breast cancer in her lifetime. Although the incidence rate is high, the survival rate after clinical treatment is also quite high. The five-year survival rate for early-stage breast cancer patients exceeds 90%, making it a highly manageable disease at present.
The incidence rate of breast cancer-related lymphedema is around 21.4%, and is expected to become increasingly common as the survival rate of patients improves. Aside from causing psychological distress, it also impairs a patient's work and daily life capabilities. Patients also have to bear additional medical expenses, which brings a significant financial burden to families. Current research supports that early detection and treatment are key to controlling breast cancer-related lymphedema. However, there is still a need for a clearer understanding of the risk factors causing lymphedema and the physiological changes that occur when it manifests, in order to achieve the goal of early detection.
This study will conduct clinical trials to investigate the mechanisms of upper limb lymphedema after breast cancer surgery. The investigators will recruit post-operative breast cancer patients and use Indocyanine Green (ICG) lymphography and Lymphoscintigraphy to detect lymphatic blockage locations; Shear Wave Elastography (SWE) to detect changes in tissue limb compliance; DXA body composition analysis to measure the differences in edema and normal limb composition ratios; and diffusion correlation spectrometry to measure deep tissue blood flow changes, along with continuous measurements of limb circumference and other physiological parameters. The study aims to explore the interrelationship among lymphatic circulation, limb circumference, tissue compliance, and tissue blood flow.
The expected results of this study can help the investigators understand the risk factors causing lymphedema and the physiological changes that occur when it manifests, overcome the current difficulties in early lymphedema detection, and develop effective monitoring methods and equipment. This will provide more possibilities for the early detection and treatment of future patients with breast cancer-related lymphedema.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
lymphoscintigraphy
circumference measurement
B-mode sono and elastography
DXA body composition analysis
Time frame: everyday, through study completion, an average of 1 year
Circumference measurements are taken and recorded at 2 cm intervals from the wrist crease to the armpit on both upper limbs
Time frame: every 1 week, through study completion, an average of 1 year
Measurements are taken every 5 cm from the wrist crease to the armpit on both upper limbs using ShearWave Elastography
Time frame: Once at the beginning of the study, and another assessment will be conducted six months later if there is a deterioration in lymphedema
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 3 months later if there is a deterioration in lymphedema
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 lymphedema
Using DXA to detect and compare the composition of both limbs at different stages after the onset of lymphedema, including changes in protein, fat, and mineral density
Contact information is provided by the study sponsor or research team.
Kaohsiung Veterans General Hospital.
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06912763
Fibrosis, Fibrosis Syndrome
Houston, Texas, United States
View Trial DetailsNCT07708662
Chronic Edema, Hemic and Lymphatic Diseases
Edegem, Antwerp, Belgium
View Trial DetailsNCT05142800
Breast Cancer, Breast Cancer Lymphedema
Boston, Massachusetts, United States
View Trial DetailsNCT06725030
Anastomosis, Surgical, Free Tissue Transfer
Beverly Hills, California, United States
View Trial Details